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NCT01943500 Clinical Trial

Collection of Blood Specimens for Circulating Tumor Cell Analysis

Breast Cancer Clinical Trial

Official title:
Collection of Blood Specimens for Circulating Tumor Cell Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01943500
Other study ID # T30-0001
Secondary ID
Status Completed
Phase N/A
First received September 10, 2013
Last updated February 13, 2017
Start date September 30, 2013
Est. completion date August 26, 2016

Study information
Verified date February 2017
Source Viatar LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date August 26, 2016
Est. primary completion date January 28, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Commonwealth Hematology-Oncology, P.C. Lawrence Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Viatar LLC Commonwealth Hematology-Oncology, P.C.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter. Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection. Analysis will be performed within 96 hours following blood sample collection
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