Collection of Blood Specimens for Circulating Tumor Cell Analysis

This study is ongoing, but not recruiting participants.
Commonwealth Hematology-Oncology, P.C.
Information provided by (Responsible Party):
Viatar LLC Identifier:
First received: September 10, 2013
Last updated: June 15, 2015
Last verified: June 2015
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).

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 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Cancer or no prior history of cancer
Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer


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.

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 identifier: NCT01943500

United States, Massachusetts
Commonwealth Hematology-Oncology, P.C.
Lawrence, Massachusetts, United States, 01841-2310
Sponsors and Collaborators
Viatar LLC
Commonwealth Hematology-Oncology, P.C.
Principal Investigator: Pedro M Sanz-Altamira, MD, PhD Commonwealth Hematology-Oncology, P.C.
  More Information

Responsible Party: Viatar LLC Identifier: NCT01943500     History of Changes
Other Study ID Numbers: T30-0001 
Study First Received: September 10, 2013
Last Updated: June 15, 2015
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:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Prostatic Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Intestinal Diseases
Intestinal Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Rectal Diseases
Urogenital Neoplasms processed this record on May 26, 2016