Stage II Bladder Urothelial Carcinoma
Conditions
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.
Interventions
PROCEDURECatheter Management
Insertion of venous catheter under ultrasound guidance
OTHERCytology Specimen Collection Procedure
Collection of blood samples
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed