Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

Stage II Bladder Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02514408
• Other study ID #: 4B-15-7
• Secondary ID: NCI-2015-010634B
• Status: Withdrawn
• Phase: N/A
• First received: July 30, 2015
• Last updated: December 28, 2017
• Start date: February 5, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: December 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Neoplastic Cells, Circulating
• Stage II Bladder Urothelial Carcinoma

Intervention

Procedure:
• Catheter Management
Insertion of venous catheter under ultrasound guidance

Other:
• Cytology Specimen Collection Procedure
Collection of blood samples
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CTCs in the blood drawn from central line	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.	Up to post-operative day 7
Primary	Number of CTCs in the blood drawn from peripheral line	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.	Up to post-operative day 7
Secondary	Incidence of complications during the cannulation of the femoral vein	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	Up to 1 month from discharge