En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 21, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on improving the way bladder tumors are removed and examined during surgery. Researchers are testing a new version of a surgical tool that may help doctors get better information about the tumors. This is important because bladder cancer is a common type of cancer, and current methods sometimes leave behind cancerous cells or lead to the tumor returning after surgery. By using this modified device, the team hopes to improve the way bladder tumor samples are prepared for analysis, which could help in understanding and treating bladder cancer more effectively.

To participate in this study, individuals must be 18 years or older and require bladder removal surgery at the NIH Clinical Center, which is often necessary for bladder cancer or other conditions. During the study, participants will still receive standard surgical care, but their bladder specimen will be prepared using the new device. They will also undergo some scans and tests before the surgery to ensure they are suitable candidates. Following the surgery, participants will continue to receive the usual follow-up care. It's important to note that pregnant women cannot participate in this trial due to potential risks to the fetus.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Patients requiring surgical removal of the bladder at the NIH Clinical Center.
• • NOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments/or participating in other trials remain eligible for enrollment in this study.
• • Men and women
• • Age greater than or less than 18 years
• • Deemed clinically appropriate for the planned surgical procedure.
• • Ability of subject to understand and the willingness to sign a written informed consent document.
• • Subjects will be asked to co-enroll in 15-C-0087, "Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients." NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.
• EXCLUSION CRITERIA:
• • - Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.