Clinical trial NCT03374267: Registry Platform Urologic Cancer
Official title: Clinical Research Platform on Urologic Cancer Treatment and Outcome (Registry Platform Urologic Cancer; CARAT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Carcinoma
Urothelial Carcinoma
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 1830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with locally advanced and inoperable, or metastatic Renal Cell Carcinoma (aRCC); locally advanced and inoperable, or metastatic Urothelial Cancer (including Bladder Cancer) (aUBC); or High-risk Muscle-Invasive Urothelial Carcinoma (High-risk MIUC)

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 or urothelial cancer in Germany.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Course of treatment (treatment reality)
timeFrame: 3 years per patient
Secondary outcomes:
measure: Best Response
timeFrame: 3 years per patient
measure: Progression-free survival
timeFrame: 3 years per patient
measure: Overall survival
timeFrame: 3 years per patient
measure: Health-related quality of life (Patient-reported outcome)
timeFrame: 2 years per patient
measure: Treatment symptom related quality of life
timeFrame: 2 years per patient
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites, Germany
Study officials:
affiliation: Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany
name: Michael Staehler, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
name: Peter Goebell, Prof. Dr.
role: STUDY_CHAIR
affiliation: Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany
name: Lothar Müller, Dr.
role: STUDY_CHAIR
affiliation: University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany
name: Viktor Grünwald, Prof. Dr.
role: STUDY_CHAIR
affiliation: Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany
name: Carsten Grüllich, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Freiburg, Dept. of Urology, Freiburg, Germany
name: Christian Gratzke, Prof. Dr.
role: STUDY_CHAIR
References: