Clinical trial NCT02514408: Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer
Official title: The Impact Radical Cystectomy Has on the Expulsion of Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stage II Bladder Urothelial Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with transitional cell bladder cancer scheduled to undergo open radical cystectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of CTCs in the blood drawn from central line
timeFrame: Up to post-operative day 7
measure: Number of CTCs in the blood drawn from peripheral line
timeFrame: Up to post-operative day 7
Secondary outcomes:
measure: Incidence of complications during the cannulation of the femoral vein
timeFrame: Up to 1 month from discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Inderbir Gill, MD
role: PRINCIPAL_INVESTIGATOR
References: