Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-04 @ 8:18 PM
Study NCT ID:
NCT03374267
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Platform Urologic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1930}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Course of treatment (treatment reality)', 'timeFrame': '3 years per patient', 'description': 'Documentation of anamnestic data and therapy sequences'}], 'secondaryOutcomes': [{'measure': 'Best Response', 'timeFrame': '3 years per patient', 'description': 'Documentation of response rates per line of treatment.'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years per patient', 'description': 'Documentation of progression-free survival per line of treatment.'}, {'measure': 'Overall survival', 'timeFrame': '3 years per patient', 'description': 'Documentation of overall survival time.'}, {'measure': 'Health-related quality of life (Patient-reported outcome)', 'timeFrame': '2 years per patient', 'description': 'Cohort aRCC: National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Cohort aUBC: NCCN/FACT Bladder Symptom Index (NCCN-FACT FBlSI-18, Version 2)'}, {'measure': 'Treatment symptom related quality of life', 'timeFrame': '2 years per patient', 'description': 'Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) - Items/Scores cohort aRCC: 3/7/15/22/24/27/28/50/51; Items/Scores cohort aUBC: 3/7/15/22/24/27/28/39/45/50/51'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma', 'Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or urothelial cancer in Germany.', 'detailedDescription': 'CARAT is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of renal cell carcinoma and urothelial cancer in Germany. The registry will follow patients with advanced renal carcinoma for up to three years, and patients with advanced urothelial cancer for up to two years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Moreover, data on perioperative therapies in patients with high-risk muscle-invasive urothelial carcinoma and radical surgery will be collected.\n\nHealth-related quality of life (HRQoL) in patients with advanced renal cell carcinoma or advanced urothelial cancel will be evaluated for up to two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with locally advanced and inoperable, or metastatic Renal Cell Carcinoma (aRCC); locally advanced and inoperable, or metastatic Urothelial Cancer (including Bladder Cancer) (aUBC); or High-risk Muscle-Invasive Urothelial Carcinoma (High-risk MIUC)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)\n* Patients at start of their first-line systemic treatment for aRCC or aUBC\n* Written informed consent\n\n * Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment\n * Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC\n* Age ≥ 18 years\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower or upper urinary tract (ICD-10 C65, C66, C67.x, C68.x). Mixed histologies are allowed (main compo-nent must be urothelial carcinoma, with minor variants accept-ed).\n* Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.\n* High-risk of recurrence, defined as follows: Post-operative, pathological tumor status\n\n * ypT2-ypT4 and/or ypN+ and without clinically detectable metastases (M0) at cystectomy for patients with prior neo-adjuvant chemotherapy or\n * pT3-pT4 and/or pN+ and without clinically detectable me-tastases (M0) at cystectomy for patients without prior neo-adjuvant chemotherapy.\n* Age ≥ 18 years at the time of surgery.\n* Written informed consent (only if patient is alive at time of data entry; not applicable for inclusion of deceased patients' data)\n\nExclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Patients with prior systemic therapy for aRCC or aUBC\n* No systemic treatment for aRCC or aUBC\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy\n* Metastatic disease (M1) at the time of surgery"}, 'identificationModule': {'nctId': 'NCT03374267', 'acronym': 'CARAT', 'briefTitle': 'Registry Platform Urologic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)', 'orgStudyIdInfo': {'id': 'iOM-110363'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aRCC', 'description': 'Patients with advanced renal cell carcinoma', 'interventionNames': ['Other: Routine care as per site standard.']}, {'label': 'aUBC', 'description': 'Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic)', 'interventionNames': ['Other: Routine care as per site standard.']}, {'label': 'High-risk MIUC', 'description': 'Patients with muscle-invasive urothelial carcinoma classified as high-risk after radical surgery (ypT2-ypT4 and/or ypN+,M0 for patients with prior neoadjuvant chemotherapy; pT3-pT4 and/or pN+, M0 for patients without prior neoadjuvant chemotherapy)', 'interventionNames': ['Other: Routine care as per site standard.']}], 'interventions': [{'name': 'Routine care as per site standard.', 'type': 'OTHER', 'description': "Physician's choice according to patient's needs.", 'armGroupLabels': ['High-risk MIUC', 'aRCC', 'aUBC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'iOMEDICO AG', 'role': 'CONTACT', 'email': 'info@iomedico.com', 'phone': '+49 761 152420'}], 'facility': 'Multiple sites, Germany'}], 'centralContacts': [{'name': 'Michaela Koska', 'role': 'CONTACT', 'email': 'info@iomedico.de', 'phone': '+49 761 15242-0'}], 'overallOfficials': [{'name': 'Michael Staehler, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany'}, {'name': 'Peter Goebell, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany'}, {'name': 'Lothar Müller, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany'}, {'name': 'Viktor Grünwald, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany'}, {'name': 'Carsten Grüllich, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany'}, {'name': 'Christian Gratzke, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Freiburg, Dept. of Urology, Freiburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}