Plataforma de Registro de Cáncer Urológico (CARAT)
Plataforma de investigación clínica sobre el tratamiento y los resultados del cáncer urológico (Plataforma de registro de cáncer urológico; 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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Michaela Koska
- Número de teléfono: +49 761 15242-0
- Correo electrónico: info@iomedico.de
Ubicaciones de estudio
-
-
-
Multiple Locations, Alemania
- Reclutamiento
- Multiple sites, Germany
-
Contacto:
- iOMEDICO AG
- Número de teléfono: +49 761 152420
- Correo electrónico: info@iomedico.com
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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).
Descripción
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)
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
aRCC
Patients with advanced renal cell carcinoma |
Physician's choice according to patient's needs. |
|
aUBC
Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic) |
Physician's choice according to patient's needs. |
|
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. |
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Course of treatment (treatment reality)
Periodo de tiempo: 3 years per patient
|
Documentation of anamnestic data and therapy sequences |
3 years per patient
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Best Response
Periodo de tiempo: 3 years per patient
|
Documentation of response rates per line of treatment. |
3 years per patient
|
|
Progression-free survival
Periodo de tiempo: 3 years per patient
|
Documentation of progression-free survival per line of treatment. |
3 years per patient
|
|
Overall survival
Periodo de tiempo: 3 years per patient
|
Documentation of overall survival time. |
3 years per patient
|
|
Health-related quality of life (Patient-reported outcome)
Periodo de tiempo: 2 years per patient
|
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
|
|
Treatment symptom related quality of life
Periodo de tiempo: 2 years per patient
|
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
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Silla de estudio: Michael Staehler, Prof. Dr., Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany
- Silla de estudio: Peter Goebell, Prof. Dr., University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany
- Silla de estudio: Lothar Müller, Dr., Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany
- Silla de estudio: Viktor Grünwald, Prof. Dr., University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany
- Silla de estudio: Carsten Grüllich, Prof. Dr., Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany
- Silla de estudio: Christian Gratzke, Prof. Dr., University Hospital Freiburg, Dept. of Urology, Freiburg, Germany
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Urológicas
- Carcinoma
- Neoplasias Renales
- Carcinoma De Célula Renal
- Carcinoma De Células De Transición
Otros números de identificación del estudio
Otros números de identificación del estudio
- iOM-110363
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .