nci-cidc-api-modules 1.2.39__py3-none-any.whl → 1.2.40__py3-none-any.whl
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- cidc_api/__init__.py +1 -1
- cidc_api/config/db.py +21 -1
- cidc_api/models/__init__.py +0 -2
- cidc_api/models/db/stage1/__init__.py +56 -0
- cidc_api/models/db/stage1/additional_treatment_orm.py +23 -0
- cidc_api/models/db/stage1/adverse_event_orm.py +47 -0
- cidc_api/models/db/stage1/base_orm.py +7 -0
- cidc_api/models/db/stage1/baseline_clinical_assessment_orm.py +23 -0
- cidc_api/models/db/stage1/comorbidity_orm.py +24 -0
- cidc_api/models/db/stage1/consent_group_orm.py +33 -0
- cidc_api/models/db/stage1/demographic_orm.py +48 -0
- cidc_api/models/db/stage1/disease_orm.py +53 -0
- cidc_api/models/db/stage1/exposure_orm.py +23 -0
- cidc_api/models/db/stage1/gvhd_diagnosis_acute_orm.py +35 -0
- cidc_api/models/db/stage1/gvhd_diagnosis_chronic_orm.py +37 -0
- cidc_api/models/db/stage1/gvhd_organ_acute_orm.py +22 -0
- cidc_api/models/db/stage1/gvhd_organ_chronic_orm.py +22 -0
- cidc_api/models/db/stage1/medical_history_orm.py +31 -0
- cidc_api/models/db/stage1/other_malignancy_orm.py +30 -0
- cidc_api/models/db/stage1/participant_orm.py +78 -0
- cidc_api/models/db/stage1/prior_treatment_orm.py +31 -0
- cidc_api/models/db/stage1/radiotherapy_dose_orm.py +40 -0
- cidc_api/models/db/stage1/response_by_system_orm.py +31 -0
- cidc_api/models/db/stage1/response_orm.py +29 -0
- cidc_api/models/db/stage1/specimen_orm.py +46 -0
- cidc_api/models/db/stage1/stem_cell_transplant_orm.py +26 -0
- cidc_api/models/db/stage1/surgery_orm.py +28 -0
- cidc_api/models/db/stage1/therapy_agent_dose_orm.py +32 -0
- cidc_api/models/db/stage1/treatment_orm.py +39 -0
- cidc_api/models/db/stage1/trial_orm.py +36 -0
- cidc_api/models/db/stage2/additional_treatment_orm.py +5 -5
- cidc_api/models/db/stage2/administrative_person_orm.py +4 -3
- cidc_api/models/db/stage2/administrative_role_assignment_orm.py +4 -3
- cidc_api/models/db/stage2/adverse_event_orm.py +11 -12
- cidc_api/models/db/stage2/arm_orm.py +3 -2
- cidc_api/models/db/stage2/base_orm.py +7 -0
- cidc_api/models/db/stage2/baseline_clinical_assessment_orm.py +5 -6
- cidc_api/models/db/stage2/cohort_orm.py +3 -2
- cidc_api/models/db/stage2/comorbidity_orm.py +6 -7
- cidc_api/models/db/stage2/consent_group_orm.py +4 -3
- cidc_api/models/db/stage2/contact_orm.py +16 -19
- cidc_api/models/db/stage2/demographic_orm.py +3 -2
- cidc_api/models/db/stage2/disease_orm.py +4 -3
- cidc_api/models/db/stage2/exposure_orm.py +3 -2
- cidc_api/models/db/stage2/file_orm.py +6 -8
- cidc_api/models/db/stage2/gvhd_diagnosis_acute_orm.py +4 -3
- cidc_api/models/db/stage2/gvhd_diagnosis_chronic_orm.py +4 -5
- cidc_api/models/db/stage2/gvhd_organ_acute_orm.py +3 -2
- cidc_api/models/db/stage2/gvhd_organ_chronic_orm.py +3 -2
- cidc_api/models/db/stage2/institution_orm.py +7 -6
- cidc_api/models/db/stage2/medical_history_orm.py +9 -8
- cidc_api/models/db/stage2/other_clinical_endpoint_orm.py +8 -11
- cidc_api/models/db/stage2/other_malignancy_orm.py +8 -9
- cidc_api/models/db/stage2/participant_orm.py +23 -23
- cidc_api/models/db/stage2/prior_treatment_orm.py +11 -10
- cidc_api/models/db/stage2/publication_orm.py +8 -9
- cidc_api/models/db/stage2/radiotherapy_dose_orm.py +8 -8
- cidc_api/models/db/stage2/response_by_system_orm.py +3 -2
- cidc_api/models/db/stage2/response_orm.py +3 -2
- cidc_api/models/db/stage2/shipment_orm.py +17 -16
- cidc_api/models/db/stage2/shipment_specimen_orm.py +4 -3
- cidc_api/models/db/stage2/specimen_orm.py +7 -5
- cidc_api/models/db/stage2/stem_cell_transplant_orm.py +5 -5
- cidc_api/models/db/stage2/surgery_orm.py +6 -6
- cidc_api/models/db/stage2/therapy_agent_dose_orm.py +7 -7
- cidc_api/models/db/stage2/treatment_orm.py +15 -14
- cidc_api/models/db/stage2/trial_orm.py +15 -16
- cidc_api/models/models.py +1 -0
- cidc_api/models/pydantic/{stage2/base.py → base.py} +1 -1
- cidc_api/models/pydantic/stage1/__init__.py +56 -0
- cidc_api/models/pydantic/stage1/additional_treatment.py +23 -0
- cidc_api/models/pydantic/stage1/adverse_event.py +100 -0
- cidc_api/models/pydantic/stage1/baseline_clinical_assessment.py +23 -0
- cidc_api/models/pydantic/stage1/comorbidity.py +36 -0
- cidc_api/models/pydantic/stage1/consent_group.py +30 -0
- cidc_api/models/pydantic/stage1/demographic.py +123 -0
- cidc_api/models/pydantic/stage1/disease.py +158 -0
- cidc_api/models/pydantic/stage1/exposure.py +32 -0
- cidc_api/models/pydantic/stage1/gvhd_diagnosis_acute.py +33 -0
- cidc_api/models/pydantic/stage1/gvhd_diagnosis_chronic.py +32 -0
- cidc_api/models/pydantic/stage1/gvhd_organ_acute.py +22 -0
- cidc_api/models/pydantic/stage1/gvhd_organ_chronic.py +23 -0
- cidc_api/models/pydantic/stage1/medical_history.py +36 -0
- cidc_api/models/pydantic/stage1/other_malignancy.py +49 -0
- cidc_api/models/pydantic/stage1/participant.py +51 -0
- cidc_api/models/pydantic/stage1/prior_treatment.py +52 -0
- cidc_api/models/pydantic/stage1/radiotherapy_dose.py +79 -0
- cidc_api/models/pydantic/stage1/response.py +65 -0
- cidc_api/models/pydantic/stage1/response_by_system.py +112 -0
- cidc_api/models/pydantic/stage1/specimen.py +52 -0
- cidc_api/models/pydantic/stage1/stem_cell_transplant.py +35 -0
- cidc_api/models/pydantic/stage1/surgery.py +49 -0
- cidc_api/models/pydantic/stage1/therapy_agent_dose.py +67 -0
- cidc_api/models/pydantic/stage1/treatment.py +50 -0
- cidc_api/models/pydantic/stage1/trial.py +45 -0
- cidc_api/models/pydantic/stage2/additional_treatment.py +2 -4
- cidc_api/models/pydantic/stage2/administrative_person.py +1 -1
- cidc_api/models/pydantic/stage2/administrative_role_assignment.py +2 -2
- cidc_api/models/pydantic/stage2/adverse_event.py +1 -1
- cidc_api/models/pydantic/stage2/arm.py +2 -2
- cidc_api/models/pydantic/stage2/baseline_clinical_assessment.py +1 -1
- cidc_api/models/pydantic/stage2/cohort.py +1 -1
- cidc_api/models/pydantic/stage2/comorbidity.py +1 -1
- cidc_api/models/pydantic/stage2/consent_group.py +2 -2
- cidc_api/models/pydantic/stage2/contact.py +1 -1
- cidc_api/models/pydantic/stage2/demographic.py +1 -1
- cidc_api/models/pydantic/stage2/disease.py +1 -1
- cidc_api/models/pydantic/stage2/exposure.py +1 -1
- cidc_api/models/pydantic/stage2/file.py +2 -2
- cidc_api/models/pydantic/stage2/gvhd_diagnosis_acute.py +1 -1
- cidc_api/models/pydantic/stage2/gvhd_diagnosis_chronic.py +1 -1
- cidc_api/models/pydantic/stage2/gvhd_organ_acute.py +1 -1
- cidc_api/models/pydantic/stage2/gvhd_organ_chronic.py +1 -1
- cidc_api/models/pydantic/stage2/institution.py +1 -1
- cidc_api/models/pydantic/stage2/medical_history.py +1 -1
- cidc_api/models/pydantic/stage2/other_clinical_endpoint.py +1 -1
- cidc_api/models/pydantic/stage2/other_malignancy.py +1 -1
- cidc_api/models/pydantic/stage2/participant.py +6 -3
- cidc_api/models/pydantic/stage2/prior_treatment.py +4 -4
- cidc_api/models/pydantic/stage2/publication.py +2 -2
- cidc_api/models/pydantic/stage2/radiotherapy_dose.py +1 -1
- cidc_api/models/pydantic/stage2/response.py +2 -2
- cidc_api/models/pydantic/stage2/response_by_system.py +1 -1
- cidc_api/models/pydantic/stage2/shipment.py +2 -2
- cidc_api/models/pydantic/stage2/shipment_specimen.py +1 -1
- cidc_api/models/pydantic/stage2/specimen.py +6 -3
- cidc_api/models/pydantic/stage2/stem_cell_transplant.py +2 -2
- cidc_api/models/pydantic/stage2/surgery.py +1 -1
- cidc_api/models/pydantic/stage2/therapy_agent_dose.py +1 -1
- cidc_api/models/pydantic/stage2/treatment.py +1 -1
- cidc_api/models/pydantic/stage2/trial.py +8 -10
- cidc_api/models/types.py +29 -1
- cidc_api/shared/gcloud_client.py +2 -2
- cidc_api/shared/utils.py +1 -0
- {nci_cidc_api_modules-1.2.39.dist-info → nci_cidc_api_modules-1.2.40.dist-info}/METADATA +1 -1
- nci_cidc_api_modules-1.2.40.dist-info/RECORD +165 -0
- cidc_api/models/db/base_orm.py +0 -25
- nci_cidc_api_modules-1.2.39.dist-info/RECORD +0 -112
- {nci_cidc_api_modules-1.2.39.dist-info → nci_cidc_api_modules-1.2.40.dist-info}/WHEEL +0 -0
- {nci_cidc_api_modules-1.2.39.dist-info → nci_cidc_api_modules-1.2.40.dist-info}/licenses/LICENSE +0 -0
- {nci_cidc_api_modules-1.2.39.dist-info → nci_cidc_api_modules-1.2.40.dist-info}/top_level.txt +0 -0
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from __future__ import annotations
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from datetime import datetime
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from sqlalchemy import ForeignKey
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from cidc_api.models.db.base_orm import BaseORM
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from cidc_api.models.db.stage2.base_orm import BaseORM
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class ShipmentSpecimenORM(BaseORM):
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sample_location: Mapped[str]
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specimen: Mapped[
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shipment: Mapped[
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specimen: Mapped[SpecimenORM] = relationship(back_populates="shipment_specimen", cascade="all, delete")
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shipment: Mapped[ShipmentORM] = relationship(back_populates="shipment_specimens", cascade="all, delete")
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from __future__ import annotations
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from cidc_api.models.types import (
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histology_behavior_description: Mapped[str | None]
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collection_event_name: Mapped[str
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specimen_type: Mapped[SpecimenType | None]
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organ_site_of_collection: Mapped[UberonAnatomicalTerm]
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from cidc_api.models.db.base_orm import BaseORM
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7
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+
from cidc_api.models.db.stage2.base_orm import BaseORM
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7
8
|
from cidc_api.models.types import YNU, OffTreatmentReason
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8
9
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9
10
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@@ -15,26 +16,26 @@ class TreatmentORM(BaseORM):
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15
16
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17
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treatment_id: Mapped[int] = mapped_column(primary_key=True)
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participant_id: Mapped[int] = mapped_column(ForeignKey("stage2.participant.participant_id", ondelete="CASCADE"))
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-
arm_id: Mapped[
|
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-
cohort_id: Mapped[
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+
arm_id: Mapped[int | None] = mapped_column(ForeignKey("stage2.arm.arm_id", ondelete="CASCADE"))
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+
cohort_id: Mapped[int | None] = mapped_column(ForeignKey("stage2.cohort.cohort_id", ondelete="CASCADE"))
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20
21
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22
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treatment_description: Mapped[str]
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23
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off_treatment: Mapped[YNU]
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-
off_treatment_reason: Mapped[
|
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-
off_treatment_reason_other: Mapped[
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+
off_treatment_reason: Mapped[OffTreatmentReason | None]
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+
off_treatment_reason_other: Mapped[str | None]
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26
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participant: Mapped[
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-
arm: Mapped[
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cohort: Mapped[
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-
adverse_events: Mapped[List[
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+
participant: Mapped[ParticipantORM] = relationship(back_populates="treatments", cascade="all, delete")
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+
arm: Mapped[ArmORM | None] = relationship(cascade="all, delete")
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+
cohort: Mapped[CohortORM | None] = relationship(cascade="all, delete")
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+
adverse_events: Mapped[List[AdverseEventORM]] = relationship(back_populates="treatment", cascade="all, delete")
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-
therapy_agent_doses: Mapped[List[
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+
therapy_agent_doses: Mapped[List[TherapyAgentDoseORM]] = relationship(
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back_populates="treatment", cascade="all, delete"
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34
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)
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34
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-
radiotherapy_doses: Mapped[List[
|
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+
radiotherapy_doses: Mapped[List[RadiotherapyDoseORM]] = relationship(
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back_populates="treatment", cascade="all, delete"
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37
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)
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-
surgeries: Mapped[List[
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-
stem_cell_transplants: Mapped[List[
|
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38
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+
surgeries: Mapped[List[SurgeryORM]] = relationship(back_populates="treatment", cascade="all, delete")
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39
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+
stem_cell_transplants: Mapped[List[StemCellTransplantORM]] = relationship(
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back_populates="treatment", cascade="all, delete"
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)
|
|
@@ -1,12 +1,13 @@
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1
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+
from __future__ import annotations
|
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1
2
|
from datetime import datetime
|
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2
|
-
from typing import List
|
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3
|
+
from typing import List
|
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3
4
|
|
|
4
5
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from sqlalchemy import ForeignKey
|
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5
6
|
from sqlalchemy.orm import Mapped, mapped_column, relationship
|
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7
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from sqlalchemy.types import JSON
|
|
7
8
|
|
|
8
|
-
from cidc_api.models.db.base_orm import BaseORM
|
|
9
|
-
from cidc_api.models.types import AssayType, TrialOrganization, TrialFundingAgency, AgeGroup
|
|
9
|
+
from cidc_api.models.db.stage2.base_orm import BaseORM
|
|
10
|
+
from cidc_api.models.types import AssayType, TrialOrganization, TrialFundingAgency, AgeGroup, PrimaryPurposeType
|
|
10
11
|
|
|
11
12
|
|
|
12
13
|
class TrialORM(BaseORM):
|
|
@@ -36,28 +37,26 @@ class TrialORM(BaseORM):
|
|
|
36
37
|
biomarker_plan: Mapped[str | None]
|
|
37
38
|
data_sharing_plan: Mapped[str | None]
|
|
38
39
|
expected_assays: Mapped[List[AssayType]] = mapped_column(JSON, nullable=True)
|
|
39
|
-
|
|
40
|
+
primary_purpose_type: Mapped[PrimaryPurposeType]
|
|
40
41
|
dbgap_study_accession: Mapped[str | None]
|
|
41
42
|
|
|
42
|
-
biobank: Mapped[
|
|
43
|
-
schema: Mapped[
|
|
44
|
-
administrative_role_assignments: Mapped[List[
|
|
43
|
+
biobank: Mapped[InstitutionORM] = relationship(back_populates="trial")
|
|
44
|
+
schema: Mapped[FileORM | None] = relationship(back_populates="trial", viewonly=True)
|
|
45
|
+
administrative_role_assignments: Mapped[List[AdministrativeRoleAssignmentORM]] = relationship(
|
|
45
46
|
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
46
47
|
)
|
|
47
|
-
arms: Mapped[List[
|
|
48
|
-
cohorts: Mapped[List[
|
|
48
|
+
arms: Mapped[List[ArmORM]] = relationship(back_populates="trial", cascade="all, delete", passive_deletes=True)
|
|
49
|
+
cohorts: Mapped[List[CohortORM]] = relationship(back_populates="trial", cascade="all, delete", passive_deletes=True)
|
|
50
|
+
participants: Mapped[List[ParticipantORM]] = relationship(
|
|
49
51
|
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
50
52
|
)
|
|
51
|
-
|
|
53
|
+
shipments: Mapped[List[ShipmentORM]] = relationship(
|
|
52
54
|
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
53
55
|
)
|
|
54
|
-
|
|
56
|
+
files: Mapped[List[FileORM]] = relationship(back_populates="trial", cascade="all, delete", passive_deletes=True)
|
|
57
|
+
publications: Mapped[List[PublicationORM]] = relationship(
|
|
55
58
|
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
56
59
|
)
|
|
57
|
-
|
|
58
|
-
publications: Mapped[List["PublicationORM"]] = relationship(
|
|
59
|
-
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
60
|
-
)
|
|
61
|
-
consent_groups: Mapped[List["ConsentGroupORM"]] = relationship(
|
|
60
|
+
consent_groups: Mapped[List[ConsentGroupORM]] = relationship(
|
|
62
61
|
back_populates="trial", cascade="all, delete", passive_deletes=True
|
|
63
62
|
)
|
cidc_api/models/models.py
CHANGED
|
@@ -3479,6 +3479,7 @@ class IngestionJobs(CommonColumns):
|
|
|
3479
3479
|
submission_id = Column(String, nullable=True)
|
|
3480
3480
|
intake_path = Column(String, nullable=True)
|
|
3481
3481
|
uploader_email = Column(String, nullable=True)
|
|
3482
|
+
is_template_downloaded = Column(Boolean, nullable=True)
|
|
3482
3483
|
|
|
3483
3484
|
@staticmethod
|
|
3484
3485
|
@with_default_session
|
|
@@ -9,7 +9,7 @@ class Base(BaseModel):
|
|
|
9
9
|
model_config = ConfigDict(
|
|
10
10
|
validate_assignment=True,
|
|
11
11
|
from_attributes=True,
|
|
12
|
-
|
|
12
|
+
extra="forbid",
|
|
13
13
|
)
|
|
14
14
|
|
|
15
15
|
# Validates the new state and updates the object if valid
|
|
@@ -0,0 +1,56 @@
|
|
|
1
|
+
from .additional_treatment import AdditionalTreatment
|
|
2
|
+
from .adverse_event import AdverseEvent
|
|
3
|
+
from .baseline_clinical_assessment import BaselineClinicalAssessment
|
|
4
|
+
from .comorbidity import Comorbidity
|
|
5
|
+
from .consent_group import ConsentGroup
|
|
6
|
+
from .demographic import Demographic
|
|
7
|
+
from .disease import Disease
|
|
8
|
+
from .exposure import Exposure
|
|
9
|
+
from .gvhd_diagnosis_acute import GVHDDiagnosisAcute
|
|
10
|
+
from .gvhd_diagnosis_chronic import GVHDDiagnosisChronic
|
|
11
|
+
from .gvhd_organ_acute import GVHDOrganAcute
|
|
12
|
+
from .gvhd_organ_chronic import GVHDOrganChronic
|
|
13
|
+
from .medical_history import MedicalHistory
|
|
14
|
+
from .other_malignancy import OtherMalignancy
|
|
15
|
+
from .participant import Participant
|
|
16
|
+
from .prior_treatment import PriorTreatment
|
|
17
|
+
from .radiotherapy_dose import RadiotherapyDose
|
|
18
|
+
from .response import Response
|
|
19
|
+
from .response_by_system import ResponseBySystem
|
|
20
|
+
from .specimen import Specimen
|
|
21
|
+
from .stem_cell_transplant import StemCellTransplant
|
|
22
|
+
from .surgery import Surgery
|
|
23
|
+
from .therapy_agent_dose import TherapyAgentDose
|
|
24
|
+
from .treatment import Treatment
|
|
25
|
+
from .trial import Trial
|
|
26
|
+
|
|
27
|
+
|
|
28
|
+
__all__ = [
|
|
29
|
+
"AdditionalTreatment",
|
|
30
|
+
"AdverseEvent",
|
|
31
|
+
"BaselineClinicalAssessment",
|
|
32
|
+
"Comorbidity",
|
|
33
|
+
"ConsentGroup",
|
|
34
|
+
"Demographic",
|
|
35
|
+
"Disease",
|
|
36
|
+
"Exposure",
|
|
37
|
+
"GVHDDiagnosisAcute",
|
|
38
|
+
"GVHDOrganAcute",
|
|
39
|
+
"GVHDDiagnosisChronic",
|
|
40
|
+
"GVHDOrganChronic",
|
|
41
|
+
"MedicalHistory",
|
|
42
|
+
"OtherMalignancy",
|
|
43
|
+
"Participant",
|
|
44
|
+
"PriorTreatment",
|
|
45
|
+
"RadiotherapyDose",
|
|
46
|
+
"Response",
|
|
47
|
+
"ResponseBySystem",
|
|
48
|
+
"Specimen",
|
|
49
|
+
"StemCellTransplant",
|
|
50
|
+
"Surgery",
|
|
51
|
+
"TherapyAgentDose",
|
|
52
|
+
"Treatment",
|
|
53
|
+
"Trial",
|
|
54
|
+
]
|
|
55
|
+
|
|
56
|
+
all_models = [globals()[cls_name] for cls_name in __all__]
|
|
@@ -0,0 +1,23 @@
|
|
|
1
|
+
from pydantic import NonNegativeInt
|
|
2
|
+
from cidc_api.models.pydantic.base import Base
|
|
3
|
+
|
|
4
|
+
|
|
5
|
+
class AdditionalTreatment(Base):
|
|
6
|
+
__data_category__ = "additional_treatment"
|
|
7
|
+
__cardinality__ = "many"
|
|
8
|
+
|
|
9
|
+
# The unique internal identifier for the AdditionalTreatment record
|
|
10
|
+
additional_treatment_id: int | None = None
|
|
11
|
+
|
|
12
|
+
# The unique internal identifier for the associated Participant record
|
|
13
|
+
participant_id: str | None = None
|
|
14
|
+
|
|
15
|
+
# Number of days from the enrollment date to the first recorded administration or occurrence of the treatment modality.
|
|
16
|
+
additional_treatment_days_to_start: NonNegativeInt | None = None
|
|
17
|
+
|
|
18
|
+
# Number of days from the enrollment date to the last recorded administration or occurrence of the treatment modality.
|
|
19
|
+
additional_treatment_days_to_end: NonNegativeInt | None = None
|
|
20
|
+
|
|
21
|
+
# Description of the prior treatment such as its full generic name if it is a type of therapy agent, radiotherapy procedure
|
|
22
|
+
# name and location, or surgical procedure name and location.
|
|
23
|
+
additional_treatment_description: str
|
|
@@ -0,0 +1,100 @@
|
|
|
1
|
+
from typing import Self
|
|
2
|
+
|
|
3
|
+
from pydantic import NonNegativeInt, model_validator
|
|
4
|
+
|
|
5
|
+
from cidc_api.models.pydantic.base import Base
|
|
6
|
+
from cidc_api.reference.ctcae import is_ctcae_other_term
|
|
7
|
+
from cidc_api.models.types import (
|
|
8
|
+
CTCAEEventTerm,
|
|
9
|
+
CTCAEEventCode,
|
|
10
|
+
SeverityGradeSystem,
|
|
11
|
+
SeverityGradeSystemVersion,
|
|
12
|
+
SeverityGrade,
|
|
13
|
+
SystemOrganClass,
|
|
14
|
+
AttributionCause,
|
|
15
|
+
AttributionLikelihood,
|
|
16
|
+
YNU,
|
|
17
|
+
)
|
|
18
|
+
|
|
19
|
+
|
|
20
|
+
class AdverseEvent(Base):
|
|
21
|
+
__data_category__ = "adverse_event"
|
|
22
|
+
__cardinality__ = "many"
|
|
23
|
+
|
|
24
|
+
# The unique internal identifier of the adverse event
|
|
25
|
+
adverse_event_id: int | None = None
|
|
26
|
+
|
|
27
|
+
# The unique internal identifier of the associated participant
|
|
28
|
+
participant_id: str | None = None
|
|
29
|
+
|
|
30
|
+
# The unique internal identifier of the attributed treatment, if any
|
|
31
|
+
treatment_id: int | None = None
|
|
32
|
+
|
|
33
|
+
# Text that represents the Common Terminology Criteria for Adverse Events low level term name for an adverse event.
|
|
34
|
+
event_term: CTCAEEventTerm | None = None
|
|
35
|
+
|
|
36
|
+
# A MedDRA code mapped to a CTCAE low level name for an adverse event.
|
|
37
|
+
event_code: CTCAEEventCode | None = None
|
|
38
|
+
|
|
39
|
+
# System used to define and report adverse event severity grade.
|
|
40
|
+
severity_grade_system: SeverityGradeSystem
|
|
41
|
+
|
|
42
|
+
# The version of the adverse event grading system.
|
|
43
|
+
severity_grade_system_version: SeverityGradeSystemVersion
|
|
44
|
+
|
|
45
|
+
# Numerical grade indicating the severity of an adverse event.
|
|
46
|
+
severity_grade: SeverityGrade
|
|
47
|
+
|
|
48
|
+
# A brief description that sufficiently details the event.
|
|
49
|
+
event_other_specify: str | None = None
|
|
50
|
+
|
|
51
|
+
# The highest level of the MedDRA hierarchy, distinguished by anatomical or physiological system, etiology (disease origin) or purpose.
|
|
52
|
+
system_organ_class: SystemOrganClass | None = None
|
|
53
|
+
|
|
54
|
+
# Indicator to identify whether a participant exited the study prematurely due to the adverse event being described.
|
|
55
|
+
discontinuation_due_to_event: bool
|
|
56
|
+
|
|
57
|
+
# Days from enrollment date to date of onset of the adverse event.
|
|
58
|
+
days_to_onset_of_event: NonNegativeInt
|
|
59
|
+
|
|
60
|
+
# Days from enrollment date to date of resolution of the adverse event.
|
|
61
|
+
days_to_resolution_of_event: NonNegativeInt | None = None
|
|
62
|
+
|
|
63
|
+
# Indicates whether the adverse event was a serious adverse event (SAE).
|
|
64
|
+
serious_adverse_event: YNU
|
|
65
|
+
|
|
66
|
+
# Indicates whether the adverse event was a dose-limiting toxicity (DLT).
|
|
67
|
+
dose_limiting_toxicity: YNU
|
|
68
|
+
|
|
69
|
+
# Indicates if the adverse was attributable to the protocol as a whole or to an individual treatment.
|
|
70
|
+
attribution_cause: AttributionCause
|
|
71
|
+
|
|
72
|
+
# The code that indicates whether the adverse event is related to the treatment/intervention.
|
|
73
|
+
attribution_likelihood: AttributionLikelihood
|
|
74
|
+
|
|
75
|
+
# The individual therapy (therapy agent, radiotherapy, surgery, stem cell transplant) in the treatment that is attributed to the adverse event.
|
|
76
|
+
individual_therapy: str | None = None
|
|
77
|
+
|
|
78
|
+
@model_validator(mode="after")
|
|
79
|
+
def validate_term_and_code_cr(self) -> Self:
|
|
80
|
+
if not self.event_term and not self.event_code:
|
|
81
|
+
raise ValueError("Please provide event_term or event_code or both")
|
|
82
|
+
return self
|
|
83
|
+
|
|
84
|
+
@model_validator(mode="after")
|
|
85
|
+
def validate_event_other_specify_cr(self) -> Self:
|
|
86
|
+
if (
|
|
87
|
+
self.severity_grade_system == "CTCAE"
|
|
88
|
+
and is_ctcae_other_term(self.event_term)
|
|
89
|
+
and not self.event_other_specify
|
|
90
|
+
):
|
|
91
|
+
raise ValueError(
|
|
92
|
+
'If severity_grade_system is "CTCAE" and the event_code or event_term are of type "Other, specify", please provide event_other_specify'
|
|
93
|
+
)
|
|
94
|
+
return self
|
|
95
|
+
|
|
96
|
+
@model_validator(mode="after")
|
|
97
|
+
def validate_system_organ_class_cr(self) -> Self:
|
|
98
|
+
if self.event_other_specify and not self.system_organ_class:
|
|
99
|
+
raise ValueError("If event_other_specify is provided, please provide system_organ_class.")
|
|
100
|
+
return self
|
|
@@ -0,0 +1,23 @@
|
|
|
1
|
+
from cidc_api.models.pydantic.base import Base
|
|
2
|
+
from cidc_api.models.types import ECOGScore, KarnofskyScore
|
|
3
|
+
|
|
4
|
+
|
|
5
|
+
class BaselineClinicalAssessment(Base):
|
|
6
|
+
__data_category__ = "baseline_clinical_assessment"
|
|
7
|
+
__cardinality__ = "one"
|
|
8
|
+
|
|
9
|
+
# A unique internal identifier for the baseline clinical assessment
|
|
10
|
+
baseline_clinical_assessment_id: int | None = None
|
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11
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+
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12
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+
# The unique identifier for the associated participant
|
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13
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+
participant_id: str | None = None
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14
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+
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15
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+
# The numerical score that represents the functional capabilities of a participant at the
|
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16
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+
# enrollment date using the Eastern Cooperative Oncology Group Performance Status assessment.
|
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17
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+
# CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=88%20and%20ver_nr=5.1
|
|
18
|
+
ecog_score: ECOGScore | None = None
|
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19
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+
|
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20
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+
# Score from the Karnofsky Performance status scale, representing the functional capabilities of a participant
|
|
21
|
+
# at the enrollment date.
|
|
22
|
+
# CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=2003853%20and%20ver_nr=4.2
|
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23
|
+
karnofsky_score: KarnofskyScore | None = None
|
|
@@ -0,0 +1,36 @@
|
|
|
1
|
+
from typing import Self
|
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2
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+
|
|
3
|
+
from pydantic import model_validator
|
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4
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+
|
|
5
|
+
from cidc_api.models.pydantic.base import Base
|
|
6
|
+
from cidc_api.models.types import ICD10CMCode, ICD10CMTerm
|
|
7
|
+
|
|
8
|
+
|
|
9
|
+
class Comorbidity(Base):
|
|
10
|
+
__data_category__ = "comorbidity"
|
|
11
|
+
__cardinality__ = "many"
|
|
12
|
+
|
|
13
|
+
# The unique internal identifier for the comorbidity record
|
|
14
|
+
comorbidity_id: int | None = None
|
|
15
|
+
|
|
16
|
+
# The unique internal identifier for the associated MedicalHistory record
|
|
17
|
+
medical_history_id: int | None = None
|
|
18
|
+
|
|
19
|
+
# The diagnosis, in humans, as captured in the tenth version of the
|
|
20
|
+
# International Classification of Disease (ICD-10-CM, the disease code subset of ICD-10).
|
|
21
|
+
comorbidity_code: ICD10CMCode | None = None
|
|
22
|
+
|
|
23
|
+
# The words from the tenth version of the International Classification of Disease (ICD-10-CM,
|
|
24
|
+
# the disease subset of ICD-10) used to identify the diagnosis in humans.
|
|
25
|
+
comorbidity_term: ICD10CMTerm | None = None
|
|
26
|
+
|
|
27
|
+
# A descriptive string that names or briefly describes the comorbidity.
|
|
28
|
+
comorbidity_other: str | None = None
|
|
29
|
+
|
|
30
|
+
@model_validator(mode="after")
|
|
31
|
+
def validate_code_or_term_or_other_cr(self) -> Self:
|
|
32
|
+
if not self.comorbidity_code and not self.comorbidity_term and not self.comorbidity_other:
|
|
33
|
+
raise ValueError(
|
|
34
|
+
'Please provide at least one of "comorbidity_code", "comorbidity_term" or "comorbidity_other".'
|
|
35
|
+
)
|
|
36
|
+
return self
|
|
@@ -0,0 +1,30 @@
|
|
|
1
|
+
from pydantic import NonNegativeInt
|
|
2
|
+
|
|
3
|
+
from cidc_api.models.pydantic.base import Base
|
|
4
|
+
|
|
5
|
+
|
|
6
|
+
class ConsentGroup(Base):
|
|
7
|
+
__data_category__ = "consent_group"
|
|
8
|
+
__cardinality__ = "one"
|
|
9
|
+
|
|
10
|
+
# The unique internal identifier for the consent group record
|
|
11
|
+
consent_group_id: int | None = None
|
|
12
|
+
|
|
13
|
+
# The unique internal identifier for the associated Trial record
|
|
14
|
+
trial_id: str | None = None
|
|
15
|
+
|
|
16
|
+
# The version number of the trial dataset
|
|
17
|
+
version: str | None = None
|
|
18
|
+
|
|
19
|
+
# An abbreviated name for the consent group
|
|
20
|
+
consent_group_short_name: str
|
|
21
|
+
|
|
22
|
+
# The words or acronym which describe a set of study participants
|
|
23
|
+
# who have signed the same consent agreement and that will be included in the dbGaP repository.
|
|
24
|
+
# CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=14534329%20and%20ver_nr=1.00
|
|
25
|
+
consent_group_name: str
|
|
26
|
+
|
|
27
|
+
# A numeral or string of numerals used to identify the set of study participants who have signed the same consent
|
|
28
|
+
# agreement and that will be included in the dbGaP repository.
|
|
29
|
+
# CDE: https://cadsr.cancer.gov/onedata/dmdirect/NIH/NCI/CO/CDEDD?filter=CDEDD.ITEM_ID=14534330%20and%20ver_nr=1.00
|
|
30
|
+
consent_group_number: NonNegativeInt
|