RecruitingNCT03374267

Registry Platform Urologic Cancer

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


Sponsor

iOMEDICO AG

Enrollment

1,930 participants

Start Date

Dec 7, 2017

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria15

  • 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 Criteria6

  • 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

Interventions

OTHERRoutine care as per site standard.

Physician's choice according to patient's needs.


Locations(1)

Multiple sites, Germany

Multiple Locations, Germany

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NCT03374267


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