Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

Withdrawn

Interventions: Procedure: Catheter Management
Other: Cytology Specimen Collection Procedure
Other: Laboratory Biomarker Analysis

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Must meet all inclusion and exclusion criteria
Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or trans-urethral resection of bladder tumor [TURBT])
Presence of a single bladder tumor lesion
Patients are scheduled to undergo ORC at our institution
Subjects must have given written informed consent to agree to participate
Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery
Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
Absolute neutrophil count (ANC) >= 1500 mm^-3
Platelet count >= 100,000 mm^-3
Hemoglobin >= 10 g/dl
Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)
Activated partial thromboplastin time =< 1.5 times ULN
Total bilirubin < 1.5 times ULN
Aspartate aminotransferase (AST) =< 3 times ULN
Alkaline phosphatase < 2 times ULN, unless arising from bone

Exclusion Criteria

Subjects deemed unsuitable candidates and not medically optimized for ORC
Subjects with tumors lying < 1 cm from sensitive structures such as the ureter, prostate or adjacent bowel
Patients with presence of multiple bladder lesions
Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma
Subjects on concurrent anticoagulant, or immunosuppressive medication
Subjects on anti-cancer medication whether biologic or pharmaceutical
Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to high intensity frequency ultrasound [HIFU] treatment)
Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
Absolute Contraindications: venous injury at the level of the femoral veins or proximally; known or suspected thrombosis of the femoral or iliac veins on the proposed side of venous annulation, ambulatory patient
Relative Contraindications: presence of bleeding disorders; distortion of anatomy due to local injury or deformity; previous long-term venous catheterization; history of vasculitis; previous injection of sclerosis agents; previous radiation therapy

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (collection of blood samples)	Cytology Specimen Collection Procedure	Patients undergo placement of a central line via the right femoral vein and undergo 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.
Ancillary-Correlative (collection of blood samples)	Catheter Management	Patients undergo placement of a central line via the right femoral vein and undergo 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.
Ancillary-Correlative (collection of blood samples)	Laboratory Biomarker Analysis	Patients undergo placement of a central line via the right femoral vein and undergo 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.

Primary Outcome Measures

Name	Time	Method
Number of CTCs in the blood drawn from central line	Up to post-operative day 7	Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.
Number of CTCs in the blood drawn from peripheral line	Up to post-operative day 7	Will estimate the mean and standard deviation (possibly after log transformation to render data compatible with the assumptions of the normal distribution) at each time point (during and after radical cystectomy) as well as the changes over time.

Secondary Outcome Measures

Name	Time	Method
Incidence of complications during the cannulation of the femoral vein	Up to 1 month from discharge	All complications will be recorded that occur during the insertion of femoral line, at any time during the surgical procedure or within 30 days of discharge from the hospital