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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03374267
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03374267
Study Brief:
Protocol Section:
NCT03374267