Collection of Blood Specimens for Circulating Tumor Cell Analysis

Completed

• Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer

• Registration Number: NCT01943500
• Lead Sponsor: Viatar LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-14
• Study First Posted: 2013-09-17
• Study Start: 2013-09-30
• Primary Completion: 2014-01-28
• Study Completion: 2016-08-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Commonwealth Hematology-Oncology, P.C.; 🇺🇸 Lawrence, Massachusetts, United States