Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-04 @ 9:00 AM
Study NCT ID:
NCT06116032
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Profiling for Cancer Immunotherapy Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood and FFPE tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to therapy', 'timeFrame': '5 years', 'description': 'The investigators will employ iRECIST, and outcome criteria will be clinically evaluated and include the primary endpoints of progression (non-responders) or response, with patients followed up every month for 6 months (or until death, loss to follow-up, or withdrawal of consent), judged according to the objective response rate (ORR) assessed using iRECIST.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy'], 'conditions': ['Cancer', 'Tumor, Solid', 'Hematologic Malignancy', 'Blood Cancer']}, 'descriptionModule': {'briefSummary': 'In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients who will receive or who are receiving immunotherapy under FDA- approved indication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).\n* Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).\n\nExclusion Criteria:\n\n* Pregnant women/fetuses/neonates\n* Prisoners\n* Decision-impaired individuals'}, 'identificationModule': {'nctId': 'NCT06116032', 'briefTitle': 'Immune Profiling for Cancer Immunotherapy Response', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Immune Profiling for Cancer Immunotherapy Response', 'orgStudyIdInfo': {'id': 'Study02001227'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care Checkpoint', 'description': 'Patients receiving standard of care FDA approved immunotherapy', 'interventionNames': ['Diagnostic Test: Methylation Cytometry']}, {'label': 'Bone Marrow Transplant', 'description': 'Patients undergoing transplant for hematologic malignancy', 'interventionNames': ['Diagnostic Test: Methylation Cytometry']}, {'label': 'CAR T', 'description': 'Patients undergoing CAR T therapy', 'interventionNames': ['Diagnostic Test: Methylation Cytometry']}], 'interventions': [{'name': 'Methylation Cytometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and in repeated measures over the duration of treatment to predict treatment response or occurrence of adverse events.', 'armGroupLabels': ['Bone Marrow Transplant', 'CAR T', 'Standard of Care Checkpoint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah G Stolrow, BA', 'role': 'CONTACT', 'email': 'hannah.stolrow@dartmouth.edu', 'phone': '7205174950'}, {'name': 'Brock C Christensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Brock C Christensen, PhD', 'role': 'CONTACT', 'email': 'brock.c.christensen@dartmouth.edu', 'phone': '603-650-1827'}, {'name': 'Hannah G Stolrow, BA', 'role': 'CONTACT', 'email': 'hannah.stolrow@dartmouth.edu', 'phone': '7205174950'}], 'overallOfficials': [{'name': 'Brock C Christensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Epidemiology, Molecular and Systems Biology, and of Community and Family Medicine', 'investigatorFullName': 'Brock C. Christensen', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}