We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Collection of Blood Specimens for Circulating Tumor Cell Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01943500
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

September 10, 2013
September 17, 2013
February 15, 2017
September 30, 2013
January 28, 2014   (Final data collection date for primary outcome 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 ]
Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.
Same as current
Complete list of historical versions of study NCT01943500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collection of Blood Specimens for Circulating Tumor Cell Analysis
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).
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.
  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
Not Provided
Cancer or no prior history of cancer
Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 26, 2016
January 28, 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01943500
T30-0001
No
Not Provided
Plan to Share IPD: No
Viatar LLC
Viatar LLC
Commonwealth Hematology-Oncology, P.C.
Principal Investigator: Pedro M Sanz-Altamira, MD, PhD Commonwealth Hematology-Oncology, P.C.
Viatar LLC
February 2017