Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT04131933
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2019-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mclemons@toh.ca', 'phone': '+1-613-737-7700', 'title': 'Dr. Mark Clemons', 'phoneExt': '70170', 'organization': 'Ottawa Hospital Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected.', 'description': 'Adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Oncotype DX Testing Ordered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3'}, {'id': 'OG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6'}, {'id': 'OG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9'}, {'id': 'OG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)", 'nonInferiorityComment': 'It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing.\n\nThis is measured as the number of participants with Oncotype DX ® testing ordered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Resection to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3'}, {'id': 'OG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6'}, {'id': 'OG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9'}, {'id': 'OG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12'}], 'classes': [{'title': 'Resection to chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '2.4'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '3.2'}]}]}, {'title': 'Resection to radiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '8.1'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.2'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '9.1'}]}]}, {'title': 'Resection to endocrine therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '7.1'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '7.6'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '9.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 Months', 'description': 'To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed are the number of participants in each period. Each row in the outcome measure data table has a different number of participants analyzed per period because not every participant received each treatment type (chemotherapy, radiation, endocrine therapy).'}, {'type': 'SECONDARY', 'title': 'Oncotype DX ® Cost', 'timeFrame': '12 Months', 'description': 'Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-12'}, {'type': 'SECONDARY', 'title': 'Physician Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3'}, {'id': 'OG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6'}, {'id': 'OG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9'}, {'id': 'OG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12'}], 'classes': [{'title': 'PREDICT results make me more confident in my recommendation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Strongly Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Neither Agree nor Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}, {'title': 'Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}, {'title': 'Strongly Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'PREDICT tool influenced my treatment decision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Strongly Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Neither Agree nor Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}, {'title': 'Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'title': 'Strongly Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'I would use PREDICT tool again', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Strongly Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Neither Agree nor Disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'Strongly Agree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Period 2 (Months 4-6) and Period 4 (Months 10-12)', 'description': 'A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Survey was only administered in Period 2 and Period 4. The number analyzed for each row differs from the overall number of participants analyzed because some surveys may have been incomplete and some items left unanswered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3'}, {'id': 'FG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6'}, {'id': 'FG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9'}, {'id': 'FG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '125'}, {'groupId': 'FG003', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '602', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Period 1', 'description': 'Patients who were seen with clinical and pathological features in Months 0-3'}, {'id': 'BG001', 'title': 'Period 2', 'description': 'Patients who were seen with clinical and pathological features in Months 4-6'}, {'id': 'BG002', 'title': 'Period 3', 'description': 'Patients who were seen with clinical and pathological features in Months 7-9'}, {'id': 'BG003', 'title': 'Period 4', 'description': 'Patients who were seen with clinical and pathological features in Months 10-12'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '602', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '11.2', 'groupId': 'BG003'}, {'value': '63.2', 'spread': '11.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '602', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '596', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-14', 'size': 388809, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-27T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2019-10-01', 'resultsFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-08', 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Oncotype DX Testing Ordered', 'timeFrame': '12 Months', 'description': 'To assess whether providing individual patient prognostic and predictive scores from PREDICT 2.1 affects the rate of subsequent requests for Oncotype DX ® testing.\n\nThis is measured as the number of participants with Oncotype DX ® testing ordered.'}], 'secondaryOutcomes': [{'measure': 'Time From Resection to Treatment', 'timeFrame': '12 Months', 'description': 'To assess whether routine availability of PREDICT 2.1 affects adjuvant treatment (chemotherapy, radiation therapy and endocrine therapy). This will be done by identifying the time to starting chemotherapy, endocrine therapy or radiation therapy.'}, {'measure': 'Oncotype DX ® Cost', 'timeFrame': '12 Months', 'description': 'Prognostic risk scores, including Magee formulae, Gage and Tennessee equations will be calculated using patient and tumour characteristics. These scores will be compared with Oncotype DX ® scores when performed. These will be used to determine Oncotype DX ® cost and total health system costs and subsequent health care utilization.'}, {'measure': 'Physician Survey', 'timeFrame': 'Period 2 (Months 4-6) and Period 4 (Months 10-12)', 'description': 'A physician survey will be used to assess physician comfort when making systemic therapy decisions.It will determine whether the routine availability of PREDICT 2.1 score in the clinic enhanced their comfort with systemic therapy decision-making.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Predict 2.1', 'Oncotype DX'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30672056', 'type': 'BACKGROUND', 'citation': 'Robertson SJ, Ibrahim MFK, Stober C, Hilton J, Kos Z, Mazzarello S, Ramsay T, Fergusson D, Vandermeer L, Mallick R, Arnaout A, Dent SF, Segal R, Sehdev S, Gertler S, Hutton B, Clemons M. Does integration of Magee equations into routine clinical practice affect whether oncologists order the Oncotype DX test? A prospective randomized trial. J Eval Clin Pract. 2019 Apr;25(2):196-204. doi: 10.1111/jep.13094. Epub 2019 Jan 23.'}, {'pmid': '31287198', 'type': 'BACKGROUND', 'citation': 'de Lima MAG, Clemons M, Van Katwyk S, Stober C, Robertson SJ, Vandermeer L, Fergusson D, Thavorn K. Cost analysis of using Magee scores as a surrogate of Oncotype DX for adjuvant treatment decisions in women with early breast cancer. J Eval Clin Pract. 2020 Jun;26(3):889-892. doi: 10.1111/jep.13223. Epub 2019 Jul 9.'}, {'pmid': '31551182', 'type': 'BACKGROUND', 'citation': 'Robertson SJ, Pond GR, Hilton J, Petkiewicz SL, Ayroud Y, Kos Z, Gravel DH, Stober C, Vandermeer L, Arnaout A, Clemons M. Selecting Patients for Oncotype DX Testing Using Standard Clinicopathologic Information. Clin Breast Cancer. 2020 Feb;20(1):61-67. doi: 10.1016/j.clbc.2019.07.006. Epub 2019 Aug 22.'}, {'pmid': '38534929', 'type': 'RESULT', 'citation': 'Awan AA, Saunders D, Pond G, Hamm C, Califaretti N, Mates M, Kumar V, Ibrahim MFK, Beltran-Bless AA, Vandermeer L, Hilton J, Clemons M. Does Pre-Emptive Availability of PREDICT 2.1 Results Change Ordering Practices for Oncotype DX? A Multi-Center Prospective Cohort Study. Curr Oncol. 2024 Feb 27;31(3):1278-1290. doi: 10.3390/curroncol31030096.'}], 'seeAlsoLinks': [{'url': 'https://react.ohri.ca/', 'label': 'The Rethinking Clinical Trials (REaCT) website'}]}, 'descriptionModule': {'briefSummary': 'A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests. It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.', 'detailedDescription': 'A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae, Gage and Tennessee equations) that incorporate standard pathology results, through to expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.\n\nIn summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician questionnaire administered. Intervention teaching after 6 months of study activation. Month 7 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1 tool used, plus physician questionnaire administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that are eligible for Oncotype DX ® testing under current funding parameters with complete pathology reports for newly diagnosed early stage breast cancer will be eligible for this prospective trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed primary breast cancer\n* No prior chemotherapy\n* Eligible for Oncotype DX ® testing as per current Ontario funding criteria including: ER positive, PR positive or negative, HER2 negative, lymph node status negative or micro-invasive disease, tumor \\>1 cm in size (or if equal or \\<1 cm, must be grade 2/3 or have lymph node micrometastasis).\n\nExclusion Criteria:\n\n* Neoadjuvant treatment including window of opportunity trials\n* Recurrent breast cancer'}, 'identificationModule': {'nctId': 'NCT04131933', 'acronym': 'REaCT-Algorith', 'briefTitle': 'Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Multi-centre, Prospective, Observational Study Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'REaCT-Algorithm'}}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Hospital', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L3P 7P3', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Markham Stouffville Hospital', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Thunder Bay Regional Health Sciences Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'N8W 1L9', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'Arif Awan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}