NCT03374267

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,230

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Dec 2017Mar 2034

Study Start

First participant enrolled

December 7, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2034

Last Updated

July 14, 2026

Status Verified

September 1, 2025

Enrollment Period

16.2 years

First QC Date

December 12, 2017

Last Update Submit

July 10, 2026

Conditions

Renal Cell CarcinomaUrothelial 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 (4)

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.

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).

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 MIUCMIBCaRCCaUBC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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); High-risk Muscle-Invasive Urothelial Carcinoma (High-risk MIUC); or patients with Muscle-Invasive Bladder Cancer (MIBC).

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.
  • Cohort MIBC (prospective)
  • +4 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple sites, Germany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale 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 15242-0info@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)

March 1, 2034

Study Completion (Estimated)

March 1, 2034

Last Updated

July 14, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)