Circulating Tumor Cells in Operative Blood in Patients With Bladder Cancer

NCT02514408 | Withdrawn DMC

• 3 other identifiers: 4B-15-7NCI-2015-01063P30CA014089
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage II Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Incidence of complications during the cannulation of the femoral vein

  Up to 1 month from discharge

Study Arms (1)

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.

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

Interventions

Catheter Management PROCEDURE

Insertion of venous catheter under ultrasound guidance

Also known as: management of catheter

Ancillary-Correlative (collection of blood samples)

Cytology Specimen Collection Procedure OTHER

Collection of blood samples

Also known as: Cytologic Sampling

Ancillary-Correlative (collection of blood samples)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (collection of blood samples)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with transitional cell bladder cancer scheduled to undergo open radical cystectomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Inderbir Gill, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: February 5, 2018
• Primary Completion: February 5, 2019
• Study Completion: March 5, 2019
• Last Updated: January 2, 2018

Record last verified: 2017-12