Study registry for the systematic documentation of urological cancers

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults. It often remains asymptomatic for a long time and is usually discovered by chance. In advanced stages, the tumor has already spread beyond the kidney or metastasized to other organs, which makes treatment more difficult. Urothelial carcinoma (UBC) primarily affects the bladder but can also occur in other parts of the urinary tract—such as the renal pelvis or the ureters. It arises from urothelial cells, which line the inner walls of these urinary organs. If the urothelial carcinoma is already advanced and has invaded the muscle layer underlying the urothelial layer, it is referred to as muscle-invasive urothelial carcinoma (MIUC). This form is more aggressive, and the risk of recurrence after treatment—which usually consists of surgical removal—is very high. Chemotherapy may also be administered before surgery to reduce the tumor size (neoadjuvant therapy). All three clinical presentations share the common characteristic that they are difficult to treat in advanced stages and often recur.

The aim of this prospective registry study is to monitor treatment courses over the long term, systematically document diagnostic and therapeutic steps, and establish a biobank for storing patient samples. The study is observational and prospective, which means that no new medications or forms of therapy are being tested, and patients are followed over a period of approximately 2 to 3 years to assess the long-term effects of guideline-based therapy. As part of the follow-up examinations, patients’ health-related quality of life will be assessed using standardized questionnaires. The primary endpoint of the study is the documentation of the course of treatment.

Women and men aged 18 and older with renal cell carcinoma (RCC), urothelial carcinoma (UBC), or muscle-invasive urothelial carcinoma (MIUC) are eligible to participate in this study. The RCC and UBC must not have been previously treated, and upon enrollment in the study, systematic, guideline-based therapy must be initiated. Additionally, the disease must be either locally advanced and inoperable or metastatic. MIUC must be classified as high-risk for recurrence following surgery (e.g., after complete removal of the bladder or the affected ureter), and no metastases may be detectable. Prior to surgery for MIUC, there must have been lymph node involvement (N+) or advanced local tumor extension (T2–T4 with neoadjuvant chemotherapy or T3–T4 without neoadjuvant chemotherapy).