Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-15 @ 11:50 AM
Study NCT ID:
NCT02784366
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2016-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GI Complications in Cancer Immunotherapy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and stool samples will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI disease activity', 'timeFrame': '12 weeks', 'description': 'To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.'}, {'measure': 'Biospecimen collection', 'timeFrame': '12 weeks', 'description': 'To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer immunotherapy', 'Ipilimumab'], 'conditions': ['Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.', 'detailedDescription': 'Primary objective\n\n* To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy\n\nSecondary objective\n\n* Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy\n* Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications\n* Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of cancer\n* Currently undergoing or have undergone immunotherapy\n\nExclusion Criteria:\n\n* History of a total colectomy\n* History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)\n* History of colitis on chemotherapy"}, 'identificationModule': {'nctId': 'NCT02784366', 'briefTitle': 'GI Complications in Cancer Immunotherapy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'GI Complications in Cancer Immunotherapy Patients', 'orgStudyIdInfo': {'id': '15302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer immunotherapy patients - no GI side effect', 'description': 'Cancer immunotherapy patients who do not develop GI side effects.'}, {'label': 'Cancer immunotherapy patients - develop GI side effects', 'description': 'Cancer immunotherapy patients who develop GI side effects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Andrews, BS', 'role': 'CONTACT', 'email': 'eaandrews@mgh.harvard.edu', 'phone': '617-724-2090'}, {'name': 'Keri Sullivan, BS', 'role': 'CONTACT', 'email': 'ksullivan79@mgh.harvard.edu', 'phone': '617-724-5955'}, {'name': 'Michael Dougan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Elizabeth Andrews, BS', 'role': 'CONTACT', 'email': 'eaandrews@mgh.harvard.edu', 'phone': '617-724-2090'}, {'name': 'Keri Sullivan, BS', 'role': 'CONTACT', 'email': 'ksullivan79@mgh.harvard.edu', 'phone': '617-724-5955'}], 'overallOfficials': [{'name': 'Michael Dougan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Ryan J Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Michael Dougan', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}