Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT05205967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REFLECTION: A Clinical Practice Learning Program for Galleri®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14633}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.', 'timeFrame': 'Up to 12 Months'}], 'secondaryOutcomes': [{'measure': 'Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.', 'timeFrame': 'Up to 12 Months'}, {'measure': 'HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.', 'timeFrame': 'Up to 12 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multi-cancer early detection', 'Cancer screening', 'Circulating cell-free tumor DNA'], 'conditions': ['Early Detection of Cancer', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '40207404', 'type': 'DERIVED', 'citation': 'Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll approximately 14,000 participants who meet the defined eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);\n* Participant is at least 22 years old at the time of consent;\n* A provider or their designee has ordered the Galleri® test; and\n* Participant has the ability to comprehend the participant questionnaires.\n\nExclusion Criteria:\n\n* There are no exclusions'}, 'identificationModule': {'nctId': 'NCT05205967', 'briefTitle': 'REFLECTION: A Clinical Practice Learning Program for Galleri®', 'organization': {'class': 'INDUSTRY', 'fullName': 'GRAIL, Inc.'}, 'officialTitle': 'REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®', 'orgStudyIdInfo': {'id': 'GRAIL-MA-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who received the Galleri® test.', 'interventionNames': ['Other: MCED', 'Other: SOC']}], 'interventions': [{'name': 'MCED', 'type': 'OTHER', 'description': 'Multi-cancer early detection (MCED) test', 'armGroupLabels': ['Patients who received the Galleri® test.']}, {'name': 'SOC', 'type': 'OTHER', 'description': 'Standard of care cancer screening', 'armGroupLabels': ['Patients who received the Galleri® test.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Vincere Cancer Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Providence, St. Jude', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Providence, Mission', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Providence, Orange County', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Miami Health Care System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'James A. Haley Veterans Hospital (VA Tampa)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02111-1750', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston VA Research Institute (VA Boston)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '18711', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Wilkes Barre Medical Center', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '29720', 'city': 'Lancaster', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Blood and Cancer Care Associate', 'geoPoint': {'lat': 34.72043, 'lon': -80.7709}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Blood and Cancer Care Associates', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'VA Salt Lake City Health Care System (VASLCHCS)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26501', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'WVU University Town Centre Family Medicine', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GRAIL, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}