Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT06962995
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Cancer Detection Observational Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Securely stored, de-identified samples and information will be used for future research'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Financial impact of MCD testing', 'timeFrame': 'Up to 5 years', 'description': 'Assessed by types of diagnostic studies ordered as a result of positive MCD test results (e.g., to establish or rule out a cancer diagnosis).'}, {'measure': 'Positive actionable MCD results', 'timeFrame': 'Up to 5 years', 'description': 'Assessed by the number of participants who receive positive MCD results'}, {'measure': 'Psychological Impact of MCD Testing', 'timeFrame': 'Baseline (after receiving MCD results)', 'description': 'Assessed with the Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA), which asks participants to evaluate their response to MCD test results over the past week. The MICRA consists of 20 items answered on a 4-point scale (Never, Rarely, Sometimes, Often). Higher scores generally indicate higher levels of distress or psychological impact.'}, {'measure': 'Change in Patient Satisfaction with MCD Test', 'timeFrame': 'Baseline; After receiving MCD results (up to 5 years)', 'description': 'Participants will complete a 3-question survey, "Satisfaction with the Multi-Cancer Detection Test." Items are answered on a 5-point scale (not at all, a little, somewhat, very, extremely).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the incorporation of Multi-Cancer Detection (MCD) testing, designed to detect many types of cancer, into clinical practice to understand both its use and effect in real world practice conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants who have undergone multi-cancer detection testing (MCD) as part of their clinical care at or outside Mayo Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has Mayo Clinic medical record number\n* Has undergone (within last 6 months) or scheduled to undergo a multi-cancer detection test (MCD) as ordered by provider\n* Able to provide informed consent\n* ≥ 21 years old\n* Ability to provide blood sample\n\nExclusion Criteria:\n\n* Individuals who have situations that would limit compliance with the study requirements\n* Institutionalized (i.e. Federal Medical Prison)\n* Known pregnancy (self-reported)\n* Currently undergoing active cancer treatment other than adjuvant hormone therapy\n* Invasive cancer diagnosis within the last 3 years'}, 'identificationModule': {'nctId': 'NCT06962995', 'briefTitle': 'Multi-Cancer Detection Observational Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Multi-Cancer Detection Observational Cohort Study', 'orgStudyIdInfo': {'id': '24-000321'}, 'secondaryIdInfos': [{'id': 'NCI-2025-03276', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients complete surveys and have their medical records reviewed on study. Patients may undergo blood or buccal swab and urine sample collection on study.', 'interventionNames': ['Procedure: Blood Sample', 'Other: Surveys']}], 'interventions': [{'name': 'Blood Sample', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collection', 'Specimen Collection', 'Blood Sample Collection'], 'description': 'Up to 60 mL (about 4-5 Tbsp) of blood may be collected for an initial blood draw and up to 30 mL (about 2-3 Tbsp) may be collected for a second blood draw, 25-45 days after first blood draw. The research blood will be collected at the time of a clinical blood draw, if possible.', 'armGroupLabels': ['Observational']}, {'name': 'Surveys', 'type': 'OTHER', 'description': 'Participants will complete surveys related to attitudes and beliefs around Multi-Cancer Detection testing.', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Jewel Samadder, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'R. John Presutti, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Ryan Hurt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Jewel Samadder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}