Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-20 @ 10:11 PM
Study NCT ID:
NCT04436393
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-17', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '18 months post Guardant360 testing', 'description': 'The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up\n\nOverall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.'}, {'measure': 'Progression Events', 'timeFrame': '18 months post Guardant360 testing', 'description': 'The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up\n\nProgression events (or progression-free survival) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.'}, {'measure': 'Subject Lost-to-Follow-Up', 'timeFrame': '18 months post Guardant360 testing', 'description': 'The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up\n\nThe length of time from date of study consent to date subject exited study prematurely due being considered lost-to-follow-up (ex. lack of response following consent)'}], 'secondaryOutcomes': [{'measure': 'Rate of biomarker discovery', 'timeFrame': '18 months post Guardant360 testing', 'description': 'Assess the rate of biomarker discovery compared to tumor genotyping results'}, {'measure': 'Time to Next Treatment', 'timeFrame': '18 months post Guardant360 testing', 'description': 'Assess time to next treatment decision compared to tumor genotyping results'}, {'measure': 'Real-world Time to Tumor Progression', 'timeFrame': '18 months post Guardant360 testing', 'description': 'Documented tumor progression either clinically or radiologically'}, {'measure': 'Real-world Overall Survival', 'timeFrame': '18 months post Guardant360 testing', 'description': 'Date of death per clinical record or secondary sources (e.g. national death registries)'}, {'measure': 'Demographics', 'timeFrame': '18 months post Guardant360 testing', 'description': 'Descriptive statistics of patient demographics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.', 'detailedDescription': 'Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing will be approached regarding participation in the study. After being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. Data related to their routine clinical care will be abstracted from medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults (18 years of age and older) with a diagnosis of breast cancer\n2. Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact\n3. Patient has previously provided contact information (either email or phone) to Guardant Health\n4. Able and willing to complete the electronic informed consent process\n5. Must have access to a computer terminal or personal computing device\n6. Willingness to consent to the release of medical records\n\nExclusion Criteria:\n\n1\\. Unable to understand English"}, 'identificationModule': {'nctId': 'NCT04436393', 'acronym': 'GRECO-B', 'briefTitle': 'Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guardant Health, Inc.'}, 'officialTitle': 'Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer', 'orgStudyIdInfo': {'id': '01-BR-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced Breast Cancer', 'description': 'Patients with diagnosis of advanced breast cancer', 'interventionNames': ['Diagnostic Test: Guardant360 test']}], 'interventions': [{'name': 'Guardant360 test', 'type': 'DIAGNOSTIC_TEST', 'description': 'tumor cfDNA testing', 'armGroupLabels': ['Advanced Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Guardant Health', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Victoria M Raymond, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guardant Health, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guardant Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}