Registry Platform Urologic Cancer

Last updated: September 17, 2024
Sponsor: iOMEDICO AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Cell Carcinoma

Urothelial Carcinoma

Kidney Cancer

Treatment

Routine care as per site standard.

Clinical Study ID

NCT03374267
iOM-110363
  • Ages > 18
  • All Genders

Study 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 or urothelial cancer in Germany.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Cohorts aRCC and aUBC (prospective)

  • Female and male patients with aRCC or aUBC (locally advanced, inoperable ormetastatic)

  • 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 andcompletion of baseline questionnaire before start of initial systemic treatment

  • Patients not participating in the PRO module: within twelve weeks after startof systemic first-line for aRCC or aUBC

  • Age ≥ 18 years

Cohort High-risk MIUC (prospective and retrospective)

  • Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower orupper 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).

  • Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.

  • High-risk of recurrence, defined as follows: Post-operative, pathological tumorstatus

  • ypT2-ypT4 and/or ypN+ and without clinically detectable metastases (M0) atcystectomy for patients with prior neo-adjuvant chemotherapy or

  • pT3-pT4 and/or pN+ and without clinically detectable me-tastases (M0) atcystectomy for patients without prior neo-adjuvant chemotherapy.

  • Age ≥ 18 years at the time of surgery.

  • Written informed consent (only if patient is alive at time of data entry; notapplicable for inclusion of deceased patients' data)

Exclusion

Exclusion Criteria:

Cohorts aRCC and aUBC (prospective)

  • Patients with prior systemic therapy for aRCC or aUBC

  • No systemic treatment for aRCC or aUBC

Cohort High-risk MIUC (prospective and retrospective)

  • Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy

  • Metastatic disease (M1) at the time of surgery

Study Design

Total Participants: 1830
Treatment Group(s): 1
Primary Treatment: Routine care as per site standard.
Phase:
Study Start date:
December 07, 2017
Estimated Completion Date:
June 30, 2027

Study 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. Moreover, data on perioperative therapies in patients with high-risk muscle-invasive urothelial carcinoma and radical surgery will be collected.

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

Connect with a study center

  • Multiple sites, Germany

    Multiple Locations,
    Germany

    Active - Recruiting

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