Collection of Blood Specimens for Circulating Tumor Cell Analysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Viatar LLC
Sponsor:
Collaborator:
Commonwealth Hematology-Oncology, P.C.
Information provided by (Responsible Party):
Viatar LLC
ClinicalTrials.gov Identifier:
NCT01943500
First received: September 10, 2013
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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


Condition
Breast Cancer
Prostate Cancer
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Collection of Blood Specimens for Circulating Tumor Cell Analysis

Resource links provided by NLM:


Further study details as provided by Viatar LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.


Estimated Enrollment: 55
Study Start Date: September 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer or no prior history of cancer
Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943500

Locations
United States, Massachusetts
Commonwealth Hematology-Oncology, P.C. Recruiting
Lawrence, Massachusetts, United States, 01841-2310
Contact: Pedro M Sanz-Altamira, MD, PhD    978-946-8230    psanz@chomed.com   
Principal Investigator: Pedro M Sanz-Altamira, MD, phD         
Sponsors and Collaborators
Viatar LLC
Commonwealth Hematology-Oncology, P.C.
Investigators
Principal Investigator: Pedro M Sanz-Altamira, MD, PhD Commonwealth Hematology-Oncology, P.C.
  More Information

No publications provided

Responsible Party: Viatar LLC
ClinicalTrials.gov Identifier: NCT01943500     History of Changes
Other Study ID Numbers: T30-0001
Study First Received: September 10, 2013
Last Updated: September 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Viatar LLC:
Breast cancer
Prostate cancer
Colorectal cancer
Circulating tumor cell (CTC)

Additional relevant MeSH terms:
Prostatic Diseases
Breast Neoplasms
Colorectal Neoplasms
Neoplastic Cells, Circulating
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 24, 2014