Registry Platform Renal Cell Carcinoma (CARAT)
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|ClinicalTrials.gov Identifier: NCT03374267|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment|
|Renal Cell Carcinoma||Other: Routine care as per site standard.|
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 in Germany. The registry will follow patients for up to three 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.
Health-related quality of life (HRQoL) in patients with renal cell carcinoma will be evaluated for up to two years.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Clinical Research Platform On Renal Cell Carcinoma Treatment And Outcome (Registry Platform Renal Cell Carcinoma; CARAT)|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
- Other: Routine care as per site standard.
Physician's choice according to patient's needs.
- Course of treatment (treatment reality) [ Time Frame: 3 years per patient ]Documentation of anamnestic data and therapy sequences
- Best Response [ Time Frame: 3 years per patient ]Documentation of response rates per line of treatment.
- Progression-free survival [ Time Frame: 3 years per patient ]Documentation of progression-free survival per line of treatment.
- Overall survival [ Time Frame: 3 years per patient ]Documentation of overall survival time.
- Health-related quality of life (Patient-reported outcome) [ Time Frame: 2 years per patient ]National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19)
- Treatment symptom related quality of life [ Time Frame: 2 years per patient ]Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) - Items/Scores: 3/7/15/22/24/27/28/50/51
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374267
|Contact: Adrian Binninger||+49 761 firstname.lastname@example.org|
|Multiple sites, Germany||Recruiting|
|Multiple Locations, Germany|
|Contact: iOMEDICO AG +49 761 152420 email@example.com|
|Study Chair:||Michael Staehler, Prof. Dr.||Urologische Klinik und Poliklinik, Klinikum der Universität München|
|Study Chair:||Peder Goebell, PD Dr.||Urologische Universitätsklinik, Waldkrankenhaus St. Marien|
|Study Chair:||Norbert Marschner, Dr.||Praxis für interdisziplinäre Onkologie & Hämatologie|
|Study Chair:||Lothar Müller, Dr.||Onkologie Leer - Emden - Papenburg|