Metadata Title NCT01980823 Eligibility Criteria Version 1.0.0 Topic FHIR Topic CQL Description NCT01980823 Eligibility Criteria Type logic-library from http://terminology.hl7.org/CodeSystem/library-type Parameter Name: Patient Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: Patient Parameter Name: Is Female Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Histologically Confirmed Breast Cancer or DCIS Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Operable Tumor With Planned Surgical Excision Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Tumor Size At Least 5mm Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Is At Least 21 Years Old Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: No Prior Treatment Within 6 Months Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Acceptable ECOG Status Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Signed Informed Consent Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: On Diabetes Or Hypercholesterolemia Medication Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: On Investigational Drug Within 6 Months Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: On Strong CYP3A4 Inhibitor Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Renal Impairment Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Gilberts Syndrome Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Has Hepatic Impairment Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Meets Inclusion Criteria Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Meets Exclusion Criteria Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Parameter Name: Is Eligible Use: Out Min Cardinality: 0 Max Cardinality: 1 Type: boolean Data Requirement Type: Condition Profile(s): Condition Code Filter(s): Path: code Code(s): SNOMED CT: 254838004 (Carcinoma of breast) Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Tumor Size Observations Data Requirement Type: Procedure Profile(s): Procedure Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code Code(s): LOINC: 89247-1 (ECOG Performance Status score) Data Requirement Type: Consent Profile(s): Consent Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code Code(s): SNOMED CT: 713670002 (Entered into drug clinical trial) Data Requirement Type: MedicationRequest Profile(s): MedicationRequest Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Serum Creatinine Lab Tests Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Aspartate Transaminase (AST/SGOT) Lab Tests Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Alanine Transaminase (ALT/SGPT) Lab Tests Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Total Bilirubin Lab Tests Data Requirement Type: Observation Profile(s): Observation Code Filter(s): Path: code ValueSet: Alkaline Phosphatase Lab Tests Library Content CQL Content library NCT01980823EligibilityCriteria version '1.0.0' using FHIR version '4.0.1' include hl7.fhir.uv.cql.FHIRHelpers version '4.0.1' called FHIRHelpers include hl7.fhir.uv.cql.FHIRCommon version '2.0.0' called FHIRCommon codesystem "SNOMED-CT": 'http://snomed.info/sct' codesystem "LOINC": 'http://loinc.org' // --- VALUESETS --- valueset "Chemotherapy or Radiation or Breast Resection Codes": 'https://example.org/fhir/ValueSet/chemo-radiation-breast-resection' valueset "Diabetes or Hypercholesterolemia Medications": 'https://example.org/fhir/ValueSet/diabetes-hypercholesterolemia-medications' valueset "Strong CYP3A4 Inhibitor Medications": 'https://example.org/fhir/ValueSet/strong-cyp3a4-inhibitors' valueset "Serum creatinine": 'https://example.org/fhir/ValueSet/serum-creatinine' //'https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.3.526.3.1139' valueset "AST": 'https://example.org/fhir/ValueSet/ast-lab-tests' valueset "ALT": 'https://example.org/fhir/ValueSet/alt-lab-tests' valueset "Total Bilirubin": 'https://example.org/fhir/ValueSet/total-bilirubin' valueset "Alkaline Phosphatase": 'https://example.org/fhir/ValueSet/alkaline-phosphatase' valueset "Core needle biopsy": 'https://example.org/fhir/ValueSet/core-needle-biopsy' valueset "Histologic test": 'https://example.org/fhir/ValueSet/histologic-test' valueset "Tumor Size Observations": 'https://example.org/fhir/ValueSet/tumor-size-observations' // --- CODES --- code "Female": '248152002' from "SNOMED-CT" display 'Female (finding)' code "Carcinoma of breast": '254838004' from "SNOMED-CT" display 'Carcinoma of breast' code "ECOG Performance Status": '89247-1' from "LOINC" display 'ECOG Performance Status score' code "Informed consent given": '203031000000107' from "SNOMED-CT" display 'Informed consent given' code "Entered into drug clinical trial": '713670002' from "SNOMED-CT" display 'Entered into drug clinical trial' // --- CONTEXT --- context Patient // =========================== // INCLUSION CRITERIA // =========================== // 1. Female define "Is Female": Patient.gender = 'female' // 2. Histologically confirmed invasive breast cancer or DCIS define "Has Histologically Confirmed Breast Cancer or DCIS": exists ( [Condition: "Carcinoma of breast"] C where C.verificationStatus ~ FHIRCommon."confirmed" and exists ( C.evidence E where E.code in "Histologic test" ) ) // 3. Operable tumor with core needle biopsy followed by surgical excision >= 2 weeks after enrollment define "Has Operable Tumor With Planned Surgical Excision": exists ( [Procedure: "Core needle biopsy"] P where P.status = 'completed' ) // Surgical excision timing (>= 2 weeks post-enrollment) assumed tracked externally // 4. Tumor size >= 5 mm by imaging or pathology define "Tumor Size At Least 5mm": exists ( [Observation: "Tumor Size Observations"] O where O.status in { 'final', 'amended' } and (O.value as FHIR.Quantity) >= 5 'mm' ) // 5. Age >= 21 years define "Is At Least 21 Years Old": AgeInYears() >= 21 // 6. No prior chemo, radiation, or breast resection within 6 months of study entry define "No Prior Treatment Within 6 Months": not exists ( [Procedure] P where P.status = 'completed' and P.code in "Chemotherapy or Radiation or Breast Resection Codes" and P.performed.toInterval() ends 6 months or less before Today() ) // 7. ECOG Performance Status 0-1 define "Has Acceptable ECOG Status": exists ( [Observation: "ECOG Performance Status"] O where O.status in { 'final', 'amended' } and (O.value as FHIR.integer) in Interval[0, 1] ) // 8. Signed informed consent define "Has Signed Informed Consent": exists ( [Consent] C where C.status = 'active' ) // =========================== // EXCLUSION CRITERIA // =========================== // 9. Currently on medication for diabetes or hypercholesterolemia define "On Diabetes Or Hypercholesterolemia Medication": exists ( [MedicationRequest] M where M.status = 'active' and M.medication in "Diabetes or Hypercholesterolemia Medications" ) // 10. Treatment with investigational drugs within 6 months define "On Investigational Drug Within 6 Months": exists ( [Observation: "Entered into drug clinical trial"] O where O.effective ends 6 months or less before Today() ) // 11. Strong CYP3A4 inhibitor use (e.g. clarithromycin, HIV protease inhibitors, itraconazole) define "On Strong CYP3A4 Inhibitor": exists ( [MedicationRequest] M where M.status = 'active' and M.medication in "Strong CYP3A4 Inhibitor Medications" ) // 12. Renal impairment: creatinine > 1.4 mg/dL define "Has Renal Impairment": exists ( [Observation: "Serum creatinine"] O where O.status in { 'final', 'amended' } and (O.value as FHIR.Quantity) > 1.4 'mg/dL' ) // TODO: Define Gilberts Syndrome define "Has Gilberts Syndrome": false define fluent function "Upper Limit of Normal"(O Observation): if exists(O.referenceRange) then O.referenceRange[0].high else null // 13. Hepatic impairment define "Has Hepatic Impairment": exists ( [Observation: "AST"] O where (O.value as FHIR.Quantity) >= 2.5 * O."Upper Limit of Normal"() ) or exists ( [Observation: "ALT"] O where (O.value as FHIR.Quantity) >= 2.5 * O."Upper Limit of Normal"() ) or exists ( [Observation: "Total Bilirubin"] O where (O.value as FHIR.Quantity) >= 1.5 * O."Upper Limit of Normal"() and not "Has Gilberts Syndrome" ) or exists ( [Observation: "Alkaline Phosphatase"] O where (O.value as FHIR.Quantity) > 2.5 * O."Upper Limit of Normal"() ) // =========================== // COMPOSITE ELIGIBILITY // =========================== define "Meets Inclusion Criteria": "Is Female" and "Has Histologically Confirmed Breast Cancer or DCIS" and "Has Operable Tumor With Planned Surgical Excision" and "Tumor Size At Least 5mm" and "Is At Least 21 Years Old" and "No Prior Treatment Within 6 Months" and "Has Acceptable ECOG Status" and "Has Signed Informed Consent" define "Meets Exclusion Criteria": "On Diabetes Or Hypercholesterolemia Medication" or "On Investigational Drug Within 6 Months" or "On Strong CYP3A4 Inhibitor" or "Has Renal Impairment" or "Has Hepatic Impairment" define "Is Eligible": "Meets Inclusion Criteria" and not "Meets Exclusion Criteria" ELM XML Content Encoded data (176168 characters) ELM JSON Content Encoded data (347016 characters) Generated using version 0.5.0 of the sample-content-ig Liquid templates
Value Set Chemotherapy or Radiation or Breast Resection Codes
Value Set Diabetes or Hypercholesterolemia Medications
Value Set Strong CYP3A4 Inhibitor Medications
Has Histologically Confirmed Breast Cancer or DCIS
Has Operable Tumor With Planned Surgical Excision
On Diabetes Or Hypercholesterolemia Medication