Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04712305
Status:
RECRUITING
Last Update Posted:
2022-01-20
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Omics Predicting IO Therapy Responses in mRCC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fresh urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '7 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '7 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '7 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': '7 years'}, {'measure': 'Adverse event of special interest (AESI)', 'timeFrame': '7 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Cell Carcinoma', 'biomarkers', 'clinical responses', 'IO-based therapies', 'metabolomics', 'proteomics', 'Urine'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.', 'detailedDescription': 'This is a multi-center single-arm translational study where patients with mRCC who are to receive pre-determined IO-based therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced and metastatic RCC patients who will receive IO-based therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 20 years\n2. Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC)\n3. Subjects who are about to receive IO-based therapy\n4. ECOG performance 0, 1, 2, and 3\n5. Life expectancy \\>3 months\n6. eGFR \\> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)\n7. Willing to sign the informed consent form\n\nExclusion Criteria:\n\n1. Subjects NOT willing to sign the informed consent form\n2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \\> 5/HPF\n3. Subjects having co-existing other malignancies that need active treatment. Those subjects with other malignancies that do not need active treatment are allowed to join the study.\n4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators\n5. Subjects who have taken any IO-based therapy before.\n6. Subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \\>4 weeks are allowed to enroll. Subjects who have received or are receiving targeted therapy are allowed to join the study.'}, 'identificationModule': {'nctId': 'NCT04712305', 'briefTitle': 'Urine Omics Predicting IO Therapy Responses in mRCC Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '202011088RIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.', 'interventionNames': ['Other: No intervention required']}, {'label': 'Cohort B', 'description': 'Validation cohort will be recruited in the next 36 months of the study period.', 'interventionNames': ['Other: No intervention required']}], 'interventions': [{'name': 'No intervention required', 'type': 'OTHER', 'description': 'No intervention required', 'armGroupLabels': ['Cohort A', 'Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yeong Shiau Pu, MD PhD', 'role': 'CONTACT', 'email': 'pu5249@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '65254'}, {'name': 'Chung Hsin Chen,, MD PhD', 'role': 'CONTACT', 'email': 'mufasachen@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '65242'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yeong Shiau Pu, MD PhD', 'role': 'CONTACT', 'email': 'pu5249@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '65254'}, {'name': 'Chung Hsin Chen, MD PhD', 'role': 'CONTACT', 'email': 'mufasachen@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '65242'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}