Registry Platform Urologic Cancer (CARAT)

March 8, 2024 updated by: iOMEDICO AG

Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)

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 advanced urothelial cancer in Germany.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Health-related quality of life (HRQoL) in patients with renal cell carcinoma or urothelial cancel will be evaluated for up to two years.

Study Type

Observational

Enrollment (Estimated)

1750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Recruiting
        • Multiple sites, Germany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with advanced renal cell carcionoma (aRCC) or advanced urothelial cancer (aUBC) requiring systemic treatment

Description

Inclusion Criteria:

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

  • 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 or aUBC
  • Age ≥ 18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aUBC
Patients with advanced urothelial carcinoma
Other: Routine care as per site standard.
Physician's choice according to patient's needs.
aRCC
Patients with advanced renal cell carcinoma
Other: Routine care as per site standard.
Physician's choice according to patient's needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality)
Time Frame: 3 years per patient
Documentation of anamnestic data and therapy sequences
3 years per patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response
Time Frame: 3 years per patient
Documentation of response rates per line of treatment.
3 years per patient
Progression-free survival
Time Frame: 3 years per patient
Documentation of progression-free survival per line of treatment.
3 years per patient
Overall survival
Time Frame: 3 years per patient
Documentation of overall survival time.
3 years per patient
Health-related quality of life (Patient-reported outcome)
Time Frame: 2 years per patient
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)
2 years per patient
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 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
2 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Michael Staehler, Prof. Dr., Urologische Klinik und Poliklinik, Klinikum der Universität München
  • Study Chair: Peter Goebell, Prof. Dr., Urologische Universitätsklinik, Waldkrankenhaus St. Marien
  • Study Chair: Lothar Müller, Dr., Onkologie Leer - Emden - Papenburg
  • Study Chair: Viktor Grünwald, Prof. Dr., Universitätsklinikum Essen (AöR), Westdeutsches Tumorzentrum Essen
  • Study Chair: Carsten Grüllich, Prof. Dr., Caritas Krankenhaus, Lebach
  • Study Chair: Christian Gratzke, Prof. Dr., Universitätsklinikum Freiburg Urologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2017

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iOM-110363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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