Collection of Blood Specimens for Circulating Tumor Cell Analysis

February 13, 2017 updated by: Viatar LLC
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Lawrence, Massachusetts, United States, 01841-2310
        • Commonwealth Hematology-Oncology, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cancer or no prior history of cancer
Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Analysis will be performed within 96 hours following blood sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viatar LLC

Collaborators

Commonwealth Hematology-Oncology, P.C.

Investigators

  • Principal Investigator: Pedro M Sanz-Altamira, MD, PhD, Commonwealth Hematology-Oncology, P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2013

Primary Completion (Actual)

January 28, 2014

Study Completion (Actual)

August 26, 2016

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 14, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T30-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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