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:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
NCT ID:
NCT02735512
Eligibility Criteria:
Inclusion Criteria:
* Subjects must meet the criteria for one of the three following groups:
* Normal patients- aged 40 years and older with no evidence of hematuria or cancer
* Patients with localized bladder cancer diagnosed by cystoscopy and pathology: T2N0M0 or T3N0M0 who have not received neoadjuvant chemotherapy
* Patients with metastatic bladder cancer: newly diagnosed with no previous treatment for metastatic disease
* Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* For normal subject arm: evidence of cancer or hematuria
* For localized bladder cancer: evidence of metastatic disease, second cancer, prior chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* For metastatic bladder cancer: prior therapy for metastatic disease
* Uncontrolled intercurrent illness including, but not limited to previous or current history of second malignancy unrelated to bladder cancer; autoimmune disease or immune deficiency, chronic treatment with immunomodulatory therapies (e.g. glucocorticoids); significant trauma, surgery, or infection in the past two weeks or psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT02735512
Study Brief:
Protocol Section:
NCT02735512