Registry Platform Urologic Cancer

NCT03374267 | Recruiting

• 1 other identifier: iOM-110363
• Study Type: observational
• Target: 1,930
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality)

  Documentation of anamnestic data and therapy sequences

  3 years per patient

Secondary Outcomes (5)

• Best Response

  3 years per patient

• Progression-free survival

  3 years per patient

• Overall survival

  3 years per patient

• Health-related quality of life (Patient-reported outcome)

  2 years per patient

• Treatment symptom related quality of life

  2 years per patient

Study Arms (3)

aRCC

Patients with advanced renal cell carcinoma

Other: Routine care as per site standard.

aUBC

Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic)

Other: Routine care as per site standard.

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)

Other: Routine care as per site standard.

Interventions

Routine care as per site standard. OTHER

Physician's choice according to patient's needs.

High-risk MIUC; aRCC; aUBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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); or High-risk Muscle-Invasive Urothelial Carcinoma (High-risk MIUC)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Multiple sites, Germany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Michael Staehler, Prof. Dr.

  Ludwig Maximilian University of Munich, Dept. of Urology - University Hospital, Munich, Germany

  STUDY CHAIR

• Peter Goebell, Prof. Dr.

  University Clinic Erlangen, Department of Urology Comprehensive Cancer Center Erlangen EMN, Erlangen, Germany

  STUDY CHAIR

• Lothar Müller, Dr.

  Onkologie UnterEms, Leer-Emden-Papenburg, Leer, Germany

  STUDY CHAIR

• Viktor Grünwald, Prof. Dr.

  University Hospital Essen West German Cancer Center Essen, Clinic for Medical Oncology and Clinic for Urology, Essen, Germany

  STUDY CHAIR

• Carsten Grüllich, Prof. Dr.

  Sana Clinic Hof, Dept. of Hematology and Oncology, Hof, Germany

  STUDY CHAIR

• Christian Gratzke, Prof. Dr.

  University Hospital Freiburg, Dept. of Urology, Freiburg, Germany

  STUDY CHAIR

Central Study Contacts

Michaela Koska

CONTACT

+49 761 15242-0; info@iomedico.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: December 7, 2017
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)