Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02978118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of T-cells before and after treatment with immune therapies', 'timeFrame': 'Baseline and Disease progression (up to two years)'}, {'measure': 'Change in the number of B-cells before and after treatment with immune therapies', 'timeFrame': 'Baseline and Disease progression (up to two years)'}, {'measure': 'Change in the number of myeloid-derived suppressor cells (MDSCs) before and after treatment with immune therapies', 'timeFrame': 'Baseline and Disease progression (up to two years)'}, {'measure': 'Change in the number of neutrophil cells before and after treatment with immune therapies', 'timeFrame': 'Baseline and Disease progression (up to two years)'}, {'measure': 'Number of patients with detectable circulating tumor cells (CTCs)', 'timeFrame': 'Disease progression (up to two years)'}], 'secondaryOutcomes': [{'measure': 'The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline', 'timeFrame': 'Baseline'}, {'measure': 'The prevalence of tumor-associated macrophages for all subjects at baseline', 'timeFrame': 'Baseline'}, {'measure': 'The change in CTCs over time', 'timeFrame': 'Baseline, week 4, week 8, week 12 and progression (up to two years)'}, {'measure': 'The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD', 'timeFrame': 'Disease progression (up to two years)'}, {'measure': 'The change in tumor burden over time measured by RECIST', 'timeFrame': 'Baseline, Week 12, Progression (up to two years)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell', 'Carcinoma, Urothelial']}, 'descriptionModule': {'briefSummary': 'This pilot study purpose of this study is to describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Duke Cancer Institute Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup A Renal Cell Carcinoma:\n\nPatients will be eligible for inclusion in this study if ALL of the following criteria apply:\n\n1. Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.\n2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan\n3. Planned initiation of treatment with any of the following:\n\n * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)\n * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.\n4. Age \\> 18 years.\n5. Ability to understand and the willingness to sign a written informed consent document.\n\nGroup B Urothelial Carcinoma:\n\nPatients will be eligible for inclusion in this study if ALL of the following criteria apply:\n\n1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.\n2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan\n3. Planned initiation of treatment with any of the following:\n\n * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)\n * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.\n4. Age \\> 18 years.\n5. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nA patient will not be eligible for inclusion in this study if any of the following criteria apply:\n\n1\\. History of intercurrent or past condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).'}, 'identificationModule': {'nctId': 'NCT02978118', 'briefTitle': 'Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies', 'orgStudyIdInfo': {'id': 'Pro00076768'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: Renal Cell Carcinoma', 'description': 'Subjects in Group A (patients with locally advanced, high grade or metastatic renal cell carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).', 'interventionNames': ['Device: Immune cell and CTC detection procedures']}, {'label': 'Group B: Urothelial Carcinoma', 'description': 'Subjects in Group B (patients with locally advanced, high grade or metastatic urothelial carcinoma starting immunotherapy) will have blood collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression on treatment for analysis of peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), metabolites, cytokines and angiokines. Urinary and fecal specimens will be collected at baseline, at the time of a standard of care cytoreductive surgery (if applicable), 12 weeks, 24 weeks, 52 weeks and upon disease progression. Tissue will be collected at the time of a standard of care cytoreductive surgery (if applicable).', 'interventionNames': ['Device: Immune cell and CTC detection procedures']}], 'interventions': [{'name': 'Immune cell and CTC detection procedures', 'type': 'DEVICE', 'description': 'Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)', 'armGroupLabels': ['Group A: Renal Cell Carcinoma', 'Group B: Urothelial Carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Daniel George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}