레지스트리 플랫폼 비뇨기과 암 (CARAT)
비뇨기암 치료 및 결과에 관한 임상 연구 플랫폼(등록 플랫폼 비뇨기암; CARAT)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Michaela Koska
- 전화번호: +49 761 15242-0
- 이메일: info@iomedico.de
연구 장소
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Multiple Locations, 독일
- 모병
- Multiple sites, Germany
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연락하다:
- iOMEDICO AG
- 전화번호: +49 761 152420
- 이메일: info@iomedico.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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); High-risk Muscle-Invasive Urothelial Carcinoma (High-risk MIUC); or patients with Muscle-Invasive Bladder Cancer (MIBC).
설명
Inclusion Criteria:
Cohorts aRCC and aUBC (prospective)
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Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)
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Patients at start of their first-line systemic treatment for aRCC or aUBC
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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
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Age ≥ 18 years
Cohort High-risk MIUC (prospective and retrospective)
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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).
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Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.
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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.
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Age ≥ 18 years at the time of surgery.
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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.
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
Cohort MIBC (prospective)
- Clinically detectable metastases (M1) at the time of diagnosis.
- Treatment in palliative intention (for tumors considered inoperable).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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aRCC
Patients with advanced renal cell carcinoma |
Physician's choice according to patient's needs. |
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aUBC
Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic) |
Physician's choice according to patient's needs. |
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High-risk MIUC
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) |
Physician's choice according to patient's needs. |
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MIBC
Patients with the diagnosis of MIBC (muscle-invasive bladder cancer; ICD-10 C67.x; cT2-T4aN0M0 or T1-T4aN1M0) and with histologically proven muscle-invasive urothelial carcinoma; mMixed histologies are allowed (main component must be urothelial histology, with minor variants accepted). |
Physician's choice according to patient's needs. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Course of treatment (treatment reality)
기간: 3 years per patient
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Documentation of anamnestic data and therapy sequences |
3 years per patient
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Best Response
기간: 3 years per patient
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Documentation of response rates per line of treatment. |
3 years per patient
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Progression-free survival
기간: 3 years per patient
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Documentation of progression-free survival per line of treatment. |
3 years per patient
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Overall survival
기간: 3 years per patient
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Documentation of overall survival time. |
3 years per patient
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Health-related quality of life (Patient-reported outcome)
기간: 2 years per patient
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Cohort aRCC: National Comprehensive Cancer Network/ Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Cohort aUBC: NCCN/FACT Bladder Symptom Index (NCCN-FACT FBlSI-18, Version 2) |
2 years per patient
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Treatment symptom related quality of life
기간: 2 years per patient
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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) - Items/Scores cohort aRCC: 3/7/15/22/24/27/28/50/51; Items/Scores cohort aUBC: 3/7/15/22/24/27/28/39/45/50/51 |
2 years per patient
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Michael Staehler, Prof. Dr., Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany
- 연구 의자: Peter Goebell, Prof. Dr., University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
- 연구 의자: Lothar Müller, Dr., Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany
- 연구 의자: Viktor Grünwald, Prof. Dr., University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany
- 연구 의자: Carsten Grüllich, Prof. Dr., Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany
- 연구 의자: Christian Gratzke, Prof. Dr., University Hospital Freiburg, Dept. of Urology, Freiburg, Germany
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- iOM-110363
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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