Overview

This trial has been completed.

Conditions breast cancer, prostate cancer, colorectal cancer
Sponsor Viatar LLC
Collaborator Commonwealth Hematology-Oncology, P.C.
Start date September 2013
End date January 2014
Trial size 14 participants
Trial identifier NCT01943500, T30-0001

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-control
Time perspective cross-sectional
Arm
Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer

Primary Outcomes

Measure
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

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

Official title Collection of Blood Specimens for Circulating Tumor Cell Analysis
Principal investigator Pedro M Sanz-Altamira, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Viatar LLC.