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Active Not Recruiting NCT02968732

Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder

Conditions: Urothelial Carcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 65
Sponsor: Fox Chase Cancer Center

Location: Fox Chase Cancer Center Philadelphia Pennsylvania

Summary

A prospective, investigational study to assess the accuracy of standardized cystoscopic evaluation with tissue sampling performed immediately prior to definitive radical cystectomy to predict pathologic tumor stage and identify patients who may benefit from bladder preservation therapy.

Eligibility Criteria

Inclusion Criteria: 1. Male or female patients age \>18 years at the time of consent. 2. Patients with a diagnosis of urothelial carcinoma clinical stage T1-T4NanyM0. 3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4. Patients must have a clinical decision to proceed with radical cystectomy by any conventional approach (open, laparoscopic, robot-assisted laparoscopic). Time from decision to surgery is usually 3-8 weeks for those who do not receive neoadjuvant chemotherapy and 10-14 weeks for those who receive neo-adjuvant chemotherapy treatment. During this time, eligibility for study participation will be verified. 5. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document or a legally authorized representative who has the ability to understand and willingness to sign a written informed consent and HIPAA authorization on behalf of the participant. 6. Women of reproductive potential must have agreed to use an effective contraceptive measure. Exclusion Criteria: 1. Patients who undergo cystectomy with non-curative intent will be excluded. 2. Patients who have undergone any prior pelvic irradiation. 3. Patients who are pregnant or nursing. Radical cystectomy and prolonged general anesthesia would place the fetus at considerable risk of demise. The prolonged recovery and debility of the patient would severely limit the patient's ability to nurse and care for an infant.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02968732). StuddyBuddy aggregates publicly available trial information.