NCT02514408

Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

The Impact Radical Cystectomy Has on the Expulsion of Circulating Tumor Cells

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the impact of radical cystectomy (surgery) on the expulsion (release) of circulating tumor cells into the blood stream in patients with bladder cancer. Significant surgery such as radical cystectomy may cause the expulsion of tumor cells. Studying the release of tumor cells into the circulation may help doctors understand the impact that radical cystectomy has on tumor metastasis and/or tumor recurrence.

Detailed description

PRIMARY OBJECTIVES: I. To detect the numbers of circulating tumor cells (CTCs) during and following radical cystectomy in both the peripheral and central line. SECONDARY OBJECTIVES: I. To ensure the safety and of using the femoral vein to access the central venous blood supply for patients with primary bladder cancer and the withdrawal of blood from both a peripheral and central line. OUTLINE: Patients undergo placement of a central line via the right femoral vein and undergo open radical cystectomy (ORC). Blood samples are collected and analyzed for CTCs pre-surgery, at 30 minutes and 1 hour once ORC begins, post-surgery, and 7 days after surgery. After completion of study, patients are followed up at 2 weeks and at 1 month.

Conditions

• Stage II Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Catheter Management	Insertion of venous catheter under ultrasound guidance
OTHER	Cytology Specimen Collection Procedure	Collection of blood samples
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-02-05
• Primary completion: 2019-02-05
• Completion: 2019-03-05
• First posted: 2015-08-03
• Last updated: 2018-01-02