Registry Platform Urologic Cancer

An observational study of Renal Cell Carcinoma and Urothelial Carcinoma, run by iOMEDICO AG at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Carcinoma, Urothelial Carcinoma
What is being tested?: Routine care as per site standard.
How many people: 2,230 participants
Where: 1 siteGermany
Study dates: 7 Dec 2017to Mar 2034
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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

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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.

Who cannot join

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

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michaela Koska contact

+49 761 15242-0

info@iomedico.de

Germany1 site, 1 recruiting

Multiple sites, Germany
Multiple Locations
iOMEDICO AG, +49 761 152420, info@iomedico.com
Recruiting

Other trials in Germany

About this study

Official title: Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)

Read the detailed description

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.

Conditions: Renal Cell Carcinoma, Urothelial Carcinoma
Being tested: Routine care as per site standard.
Medical subject headings: Carcinoma, Renal Cell, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Routine care as per site standard.Other
Physician's choice according to patient's needs.

Study groups in NCT03374267
Study group	Role	What they receive
aRCC		Patients with advanced renal cell carcinoma Receives: Other: Routine care as per site standard.
aUBC		Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic) Receives: 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) Receives: 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). Receives: Other: Routine care as per site standard.

What is being measured

The primary outcome is the main question the study is designed to answer.

Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Measured: 3 years per patient

Secondary outcomes (5)

Best Response
Documentation of response rates per line of treatment.
Measured: 3 years per patient
Progression-free survival
Documentation of progression-free survival per line of treatment.
Measured: 3 years per patient
Overall survival
Documentation of overall survival time.
Measured: 3 years per patient
Health-related quality of life (Patient-reported outcome)
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)
Measured: 2 years per patient
Treatment symptom related quality of life
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
Measured: 2 years per patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 2017Mar 2034

First posted15 Dec 2017
Study start7 Dec 2017
Primary completionMar 2034 (estimated)
Study completionMar 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,230 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03374267
Sponsor's protocol ID: iOM-110363
Acronym: CARAT
Status last verified: Sep 2025
First submitted: 12 Dec 2017
Last updated: 14 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Michaela Koska

+49 761 15242-0

info@iomedico.de

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)
ClinicalTrials.gov ID: NCT03374267
Acronym / sponsor ID: CARAT / iOM-110363
Conditions: Renal Cell Carcinoma, Urothelial Carcinoma
Study type: Observational
Recruitment status: Recruiting
Enrolment: 2,230 participants (estimated)
Lead sponsor: iOMEDICO AGIndustry (pharma, biotech, devices)
Study start: 7 Dec 2017 (actual)
Primary completion: Mar 2034 (estimated)
Study completion: Mar 2034 (estimated)
First posted: 15 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 4

Arm	Type	Receives
aRCC	–	Other: Routine care as per site standard.Patients with advanced renal cell carcinoma
aUBC	–	Other: Routine care as per site standard.Patients with advanced urothelial carcinoma (locally advanced and inoperable, or metastatic)
High-risk MIUC	–	Other: Routine care as per site standard.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)
MIBC	–	Other: Routine care as per site standard.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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (20 listed)

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
Age ≥ 18 years

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Routine care as per site standard.Physician's choice according to patient's needs.	Other	High-risk MIUC, MIBC, aRCC, aUBC

Primary outcome

Course of treatment (treatment reality)
Time frame: 3 years per patient
Documentation of anamnestic data and therapy sequences

5 secondary outcomes

Best Response
Time frame: 3 years per patient
Progression-free survival
Time frame: 3 years per patient
Overall survival
Time frame: 3 years per patient
Health-related quality of life (Patient-reported outcome)
Time frame: 2 years per patient
Treatment symptom related quality of life
Time frame: 2 years per patient

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Renal Cell Carcinoma

RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruiting
App-Based Mindfulness Intervention for the Improvement of Quality of Life in Patients With Metastatic Renal Cell Cancer
Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Michaela Koska contact

+49 761 15242-0

info@iomedico.de

Michael Staehler, Prof. Dr. study chair

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

Peter Goebell, Prof. Dr. study chair

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

Lothar Müller, Dr. study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma and Urothelial Carcinoma, run by iOMEDICO AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michaela Koska (+49 761 15242-0, info@iomedico.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Course of treatment (treatment reality) (time frame: 3 years per patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03374267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.