Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

NCT ID: NCT02514408

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2019-03-05

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.

Conditions

Stage II Bladder Urothelial Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Ancillary-Correlative (collection of blood samples)

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.

Catheter Management

Intervention Type: PROCEDURE

Insertion of venous catheter under ultrasound guidance

Cytology Specimen Collection Procedure

Intervention Type: OTHER

Collection of blood samples

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Catheter Management

Insertion of venous catheter under ultrasound guidance

Intervention Type: PROCEDURE

Cytology Specimen Collection Procedure

Collection of blood samples

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

management of catheter; Cytologic Sampling

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inderbir Gill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Other Identifiers

NCI-2015-01063

Identifier Type: REGISTRY

Identifier Source: secondary_id

4B-15-7

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4B-15-7

Identifier Type: -

Identifier Source: org_study_id