Registry Platform Urologic Cancer

Официальное название

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

Обзор

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.

Подробное описание

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, patients with advanced urothelial cancer for up to two years and patients with muscle-invasive bladder cancer for up to five 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. Additionally for patients with muscle-invasive bladder cancer data on (neo)adjuvant systemic therapies and details on surgeries 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.

Вмешательства

• Другое Routine care as per site standard.
  Physician's choice according to patient's needs.

Первичные конечные точки

• Course of treatment (treatment reality) [Срок оценки: 3 years per patient]

Вторичные конечные точки (5)

• Best Response [Срок оценки: 3 years per patient]
• Progression-free survival [Срок оценки: 3 years per patient]
• Overall survival [Срок оценки: 3 years per patient]
• Health-related quality of life (Patient-reported outcome) [Срок оценки: 2 years per patient]
• Treatment symptom related quality of life [Срок оценки: 2 years per patient]

Критерии участия

Критерии включения

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)

Cohort MIBC (prospective)

• Diagnosis of MIBC (muscle-invasive bladder cancer; ICD-10 C67.x; cT2-T4aN0M0 or T1-T4aN1M0).
• Histologically proven muscle-invasive urothelial carcinoma. Mixed histologies are allowed (main component must be urothelial histology, with minor variants accepted).
• Age ≥ 18 years at the time of diagnosis.
• Written informed consent within 15 weeks from diagnosis of MIBC.

Критерии исключения

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

Cohort MIBC (prospective)

• Clinically detectable metastases (M1) at the time of diagnosis.
• Treatment in palliative intention (for tumors considered inoperable).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Multiple sites, Germany — Multiple Locations

Идентификаторы

NCT: NCT03374267 · iOM-110363

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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