Collection of Blood Specimens for Circulating Tumor Cell Analysis

Viatar LLC1 site in 1 country14 target enrollmentSeptember 30, 2013

ConditionsBreast Cancer Prostate Cancer Colorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Viatar LLC
Enrollment: 14
Locations: 1
Primary Endpoint: The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).

Registry

clinicaltrials.gov

Start Date

September 30, 2013

End Date

August 26, 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Viatar LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years of age
•Written informed consent obtained
•Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer
•Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients
•Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject

Exclusion Criteria

•Patients unable to understand the research protocol and/or provide informed consent.
•Patients with known immunodeficiency, or pregnancy.

Outcomes

Primary Outcomes

The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.

Time Frame: Analysis will be performed within 96 hours following blood sample collection

Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.