注册平台泌尿系统癌症 (CARAT)
泌尿系统癌症治疗和结果临床研究平台(Registry Platform Urologic Cancer; 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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Michaela Koska
- 电话号码:+49 761 15242-0
- 邮箱:info@iomedico.de
学习地点
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Multiple Locations、德国
- 招聘中
- Multiple sites, Germany
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接触:
- iOMEDICO AG
- 电话号码:+49 761 152420
- 邮箱:info@iomedico.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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).
描述
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).
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Course of treatment (treatment reality)
大体时间:3 years per patient
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Documentation of anamnestic data and therapy sequences |
3 years per patient
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Best Response
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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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合作者和调查者
赞助
调查人员
- 学习椅:Michael Staehler, Prof. Dr.、Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany
- 学习椅:Peter Goebell, Prof. Dr.、University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
- 学习椅:Lothar Müller, Dr.、Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany
- 学习椅:Viktor Grünwald, Prof. Dr.、University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany
- 学习椅:Carsten Grüllich, Prof. Dr.、Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany
- 学习椅:Christian Gratzke, Prof. Dr.、University Hospital Freiburg, Dept. of Urology, Freiburg, Germany
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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