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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
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

Brief Summary:
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 in Germany.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Other: Routine care as per site standard.

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • Other: Routine care as per site standard.
    Physician's choice according to patient's needs.


Primary Outcome Measures :
  1. Course of treatment (treatment reality) [ Time Frame: 3 years per patient ]
    Documentation of anamnestic data and therapy sequences


Secondary Outcome Measures :
  1. Best Response [ Time Frame: 3 years per patient ]
    Documentation of response rates per line of treatment.

  2. Progression-free survival [ Time Frame: 3 years per patient ]
    Documentation of progression-free survival per line of treatment.

  3. Overall survival [ Time Frame: 3 years per patient ]
    Documentation of overall survival time.

  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with advanced renal cell carcionoma (aRCC) requiring systemic treatment
Criteria

Inclusion Criteria:

  • Female and male patients with aRCC (locally advanced, inoperable or metastatic)
  • Patients at start of their first-line systemic treatment for aRCC
  • Written informed consent

    • Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment
    • Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC
  • Age ≥ 18 years
  • Patients participating in the PRO module: Sufficient knowledge of the German language to fill-in the questionnaires

Exclusion Criteria:

  • Patients with prior systemic therapy for aRCC
  • No systemic treatment for aRCC

Information from the National Library of Medicine

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


Contacts
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Contact: Adrian Binninger +49 761 15242-0 info@iomedico.de

Locations
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Germany
Multiple sites, Germany Recruiting
Multiple Locations, Germany
Contact: iOMEDICO AG    +49 761 152420    info@iomedico.com   
Sponsors and Collaborators
iOMEDICO AG
Investigators
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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
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Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT03374267    
Other Study ID Numbers: iOM-110363
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases