Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-02 @ 3:08 PM
Study NCT ID:
NCT04144751
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood samples will be de-identified.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23494}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood-based biomarkers associated with genetic and epigenetic alterations.', 'timeFrame': 'Point in time blood collection (1 day) at enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Draw'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).', 'detailedDescription': 'Subjects who consent to enroll in Exact Sciences Protocol 2019-01 BLUE-C, will be invited to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2019-01 BLUE-C, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Up to 24,000 subjects will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.\n2. Subject is willing and able to provide a blood sample.\n3. Subject is willing and able to sign informed consent.\n\nExclusion Criteria:\n\n1\\. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.'}, 'identificationModule': {'nctId': 'NCT04144751', 'briefTitle': 'Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exact Sciences Corporation'}, 'officialTitle': 'Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"', 'orgStudyIdInfo': {'id': '2019-01B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects Enrolled in 2019-01 BLUE-C', 'description': 'Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Subjects will provide a blood sample at time of enrollment.', 'interventionNames': ['Other: Blood Sample Collection']}], 'interventions': [{'name': 'Blood Sample Collection', 'type': 'OTHER', 'description': 'Subjects participating in the study will have blood drawn at enrollment.', 'armGroupLabels': ['Subjects Enrolled in 2019-01 BLUE-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Summit Internal Medicine, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cullman Clinical Trials', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'G & L Research', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'East View Medical Research, LLC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'GI Associates of West Alabama, P.C', 'geoPoint': {'lat': 33.20984, 'lon': 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