Registry Platform Urologic Cancer

Launched by IOMEDICO AG · Dec 12, 2017

Keywords

ClinConnect Summary

This clinical trial, called the Registry Platform Urologic Cancer, is focused on understanding and collecting important information about patients with advanced renal cell carcinoma (a type of kidney cancer) and urothelial carcinoma (a type of bladder cancer). The goal is to create a national database that tracks data on patient characteristics, treatment responses, and disease progression over time. This will help researchers and doctors improve care for future patients. The study is currently recruiting participants across Germany.

To be eligible for this trial, patients must be at least 18 years old and diagnosed with advanced renal cell carcinoma or urothelial carcinoma that is either locally advanced, inoperable, or has spread (metastatic). Participants must also be starting their first round of systemic treatment (medications that work throughout the body) for their cancer. Those who join will be asked to provide informed consent and may complete a questionnaire about their experiences and health before starting treatment. This trial aims to gather valuable long-term data, which may lead to better treatments and outcomes for people with these types of cancer.

Gender

ALL

Eligibility criteria

• 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)
• 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