Health TrialsbyHealthPanel

Registry Platform Urologic Cancer

ConditionsRenal Cell CarcinomaUrothelial Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with prior systemic therapy for aRCC or aUBC

No systemic treatment for aRCC or aUBC

Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy

Metastatic disease (M1) at the time of surgery

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine care as per site standard.

    Other intervention

    Physician's choice according to patient's needs.

Treatment groups

2,230 Participants
are divided into 4 treatment groups
Group A: aRCC1 intervention
Group B: aUBC1 intervention
Group C: High-risk MIUC1 intervention
Group D: MIBC1 intervention

Trial outcomes

Primary outcomes

1

Course of treatment (treatment reality)

Documentation of anamnestic data and therapy sequences

Time frame
3 years per patient

Secondary outcomes

1

Best Response

Documentation of response rates per line of treatment.

Time frame
3 years per patient
2

Progression-free survival

Documentation of progression-free survival per line of treatment.

Time frame
3 years per patient
3

Overall survival

Documentation of overall survival time.

Time frame
3 years per patient
4

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)

Time frame
2 years per patient

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Multiple sites, GermanyRecruiting Multiple LocationsGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

iOMEDICO AG

Lead sponsor

Source ClinicalTrials.gov
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