Collection of Blood Specimens for Circulating Tumor Cell Analysis

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Commonwealth Hematology-Oncology, P.C.

Lawrence, Massachusetts, 01841-2310, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Viatar LLC

Industry

Collaborators

Commonwealth Hematology-Oncology, P.C.

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Sep 17, 2013
Registry last updated: Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed