Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06235268
Eligibility Criteria:
Inclusion Criteria:
* Cytological and/or histological diagnosis of urothelial carcinoma or at least with one urothelial component originating from the genitourinary tract.
* Radiological diagnosis of metastatic or locally advanced disease inoperable
* Primary bladder, ureter, renal pelvis and of the urethra are included
* No previous chemotherapy for advanced urothelial carcinoma or metastatic disease
* Age over 18 years old
* Ability to understand and sign the informed consent
* Patients for whom the clinician has opted for a therapeutic path not including active systemic treatments (iter palliative or observation) with certain diagnosis of metastatic disease
* Patients with lymph node extension of the disease who are not candidates to neoadjuvant treatment
* Any ECOG PS and therapeutic management is permitted.
* Previous surgeries and antineoplastic treatments are permitted as long as not carried out for metastatic disease (adjuvant and/or neoadjuvant)
Exclusion Criteria:
* Patients who have received previous systemic treatment for metastatic disease
* Patients with histological and/or cytological diagnosis without urothelial component
* Patients with muscle-infiltrating disease without evidence of metastatic disease
* Patients with non-muscle infiltrating disease without evidence of metastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06235268
Study Brief:
Protocol Section:
NCT06235268