Registry Platform Urologic Cancer (CARAT)

iOMEDICO

Status: Enrolling

Conditions: Urothelial Carcinoma; Renal Cell Carcinoma

Treatments: Other: Routine care as per site standard.

Study type: Observational

Funder types: Industry

Identifiers

NCT03374267

iOM-110363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,930 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohorts aRCC and aUBC (prospective)

• 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

Cohort High-risk MIUC (prospective and retrospective)

• 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).

• 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 tumor status

  • ypT2-ypT4 and/or ypN+ and without clinically detectable metastases (M0) at cystectomy for patients with prior neo-adjuvant chemotherapy or
  • pT3-pT4 and/or pN+ and without clinically detectable me-tastases (M0) at cystectomy 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; not applicable for inclusion of deceased patients' data)

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

Trial design

1,930 participants in 3 patient groups

aRCC

Description:

Patients with advanced renal cell carcinoma

Treatment:

Other: Routine care as per site standard.

aUBC

Description:

Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic)

Treatment:

Other: Routine care as per site standard.

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)

Treatment:

Other: Routine care as per site standard.