Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05673018
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Galleri® in the Medicare Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The parallel arm is a passively-enrolled contemporaneous comparator cohort of Medicare beneficiaries who receive usual care without MCED screening.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rates of stage IV cancers', 'timeFrame': 'Up to 3 Years'}], 'secondaryOutcomes': [{'measure': 'Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result', 'timeFrame': 'Up to 3 Years'}, {'measure': 'Galleri test performance in the Galleri + UC arm', 'timeFrame': 'Up to 3 Years'}, {'measure': 'Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time', 'timeFrame': 'Up to 3 Years'}, {'measure': 'Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm', 'timeFrame': 'Up to 3 Years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ctDNA, Circulating tumor DNA, Screening, Cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek enrollment that is representative of the Medicare population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor Galleri + UC (Galleri-Tested Arm):\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A \\& B or Dual Eligibles) or Medicare Advantage.\n* Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).\n\nFor UC (Not Galleri-tested Arm):\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \\& B or Dual Eligibles) or Medicare Advantage.\n* Have had ≥ 1 UC visit\n\nExclusion Criteria:\n\nFor Galleri + UC (Galleri-Tested Arm):\n\n* Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.\n* Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):\n\n 1. Diagnosed ≤3 years before expected enrollment date and/or\n 2. Diagnosed \\>3 years before expected enrollment date and never treated and/or\n 3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).\n* Current pregnancy.\n* Individuals who are currently inpatients at a participating site.\n* Individuals who are not willing or able to comply with the protocol procedures.\n* Individuals who are not currently registered patients at a participating center.\n* Previous or current employees or contractors of GRAIL.\n\nFor UC (Not Galleri-tested Arm):\n\n* Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.\n* Undergoing clinical evaluation for suspicion of cancer.\n* Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):\n\n 1. Diagnosed ≤3 years before expected enrollment date and/or\n 2. Diagnosed \\>3 years before expected enrollment date and never treated and/or\n 3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).\n* Current pregnancy.\n* Individuals who are currently inpatients at a participating site."}, 'identificationModule': {'nctId': 'NCT05673018', 'briefTitle': 'Galleri® in the Medicare Population.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GRAIL, Inc.'}, 'officialTitle': 'REACH Study: Galleri® in the Medicare Population.', 'orgStudyIdInfo': {'id': 'GRAIL-MA-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Galleri + UC)', 'description': 'Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).', 'interventionNames': ['Device: Multi-Cancer Early Detection Test (Galleri®)']}, {'type': 'NO_INTERVENTION', 'label': '(UC) alone', 'description': 'Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.'}], 'interventions': [{'name': 'Multi-Cancer Early Detection Test (Galleri®)', 'type': 'DEVICE', 'description': 'Blood collection and multi-cancer early detection testing with return of results.', 'armGroupLabels': ['(Galleri + UC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95603', 'city': 'Auburn', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Auburn', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '95616', 'city': 'Davis', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95758', 'city': 'Elk Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Elk Grove', 'geoPoint': {'lat': 38.4088, 'lon': -121.37162}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Fuentes', 'role': 'CONTACT', 'email': 'Afuentes1@memorialcare.org', 'phone': '562-760-6849'}], 'facility': 'Long Beach Memorial Orange Coast', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Fuentes', 'role': 'CONTACT', 'email': 'Afuentes1@memorialcare.org', 'phone': '562-760-6849'}], 'facility': 'Long Beach Memorial Saddleback', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Fuentes', 'role': 'CONTACT', 'email': 'Afuentes1@memorialcare.org', 'phone': '562-760-6849'}], 'facility': 'Long Beach Memorial Atlantic', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals PAMF Sutter', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Alhambra', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Capitol Pavilion', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Corinne Sears', 'role': 'CONTACT', 'email': 'REACHMCD@ucsf.edu', 'phone': '415-205-0182'}], 'facility': 'University of California San Francisco Health System', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95065', 'city': 'Santa Cruz', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals PAMF Santa Cruz', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Health Santa Rosa', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals PAMF Sunnyvale', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie A Jacobs', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org', 'phone': '916-746-2161'}], 'facility': 'Sutter Valley Hospitals Fairfield', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea Greer', 'role': 'CONTACT', 'email': 'totalcancercare@msm.edu', 'phone': '404-752-1034'}], 'facility': 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-90.10042}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health STCC', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70065', 'city': 'Kenner', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health Kenner', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health Lafayette', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health Westbank', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '70003', 'city': 'Metairie', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health Lafreniere', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Lovell', 'role': 'CONTACT', 'email': 'Ellen.Lovell@Ochsner.org', 'phone': '504-842-8196'}], 'facility': 'Ochsner Health Benson', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Damon Broyles', 'role': 'CONTACT', 'email': 'MercyResearchREACHStudy@Mercy.net'}], 'facility': 'Mercy Health - Springfield', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Damon Broyles', 'role': 'CONTACT', 'email': 'MercyResearchREACHStudy@Mercy.net'}], 'facility': 'Mercy Health St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '97006', 'city': 'Beaverton', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Potts', 'role': 'CONTACT', 'email': 'REACH@ohsu.edu', 'phone': '503-418-8150'}], 'facility': 'OHSU CEDAR Clinical Trials Beaverton', 'geoPoint': {'lat': 45.48706, 'lon': -122.80371}}, {'zip': '97124', 'city': 'Hillsboro', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Potts', 'role': 'CONTACT', 'email': 'REACH@ohsu.edu', 'phone': '503-418-8150'}], 'facility': 'OHSU CEDAR Clinical Trials Orenco', 'geoPoint': {'lat': 45.52289, 'lon': -122.98983}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Potts', 'role': 'CONTACT', 'email': 'REACH@ohsu.edu', 'phone': '503-418-8150'}], 'facility': 'OHSU CEDAR Clinical Trials Portland', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97202', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Potts', 'role': 'CONTACT', 'email': 'REACH@ohsu.edu', 'phone': '503-418-8150'}], 'facility': 'OHSU CEDAR Clinical Trials Richmond', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17815', 'city': 'Bloomsburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Honushefsky', 'role': 'CONTACT', 'email': 'amhonushefsky@geisinger.edu', 'phone': '570-293-7170'}], 'facility': 'Geisinger Bloomsburg Hospital', 'geoPoint': {'lat': 41.0037, 'lon': -76.45495}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kellie Graves', 'role': 'CONTACT', 'email': 'Kellie.Graves@hcahealthcare.com', 'phone': '615-507-2247'}], 'facility': 'HCA Healthcare Brentwood', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kellie Graves', 'role': 'CONTACT', 'email': 'Kellie.Graves@hcahealthcare.com', 'phone': '615-507-2247'}], 'facility': 'HCA Healthcare Centennial', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kellie Graves', 'role': 'CONTACT', 'email': 'Kellie.Graves@hcahealthcare.com', 'phone': '615-507-2247'}], 'facility': 'HCA Healthcare Nashville', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '26501', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Courtney Pilkerton', 'role': 'CONTACT', 'email': 'DFMresearch@wvumedicine.org', 'phone': '304-285-7250'}], 'facility': 'West Virginia University Health System', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'GRAIL Medical Information', 'role': 'CONTACT', 'email': 'customerservice@grail.com', 'phone': '833-694-2553'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GRAIL, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}