Collection of Blood Specimens for Circulating Tumor Cell Analysis

NCT01943500 | Completed

• 1 other identifier: T30-0001
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Prostate Cancer; Colorectal Cancer

Keywords

Breast cancer; Prostate cancer; Colorectal cancer; Circulating tumor cell (CTC)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cancer or no prior history of cancer

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to understand the research protocol and/or provide informed consent.
• Patients with known immunodeficiency, or pregnancy.

Sponsors & Collaborators

• Viatar LLC: lead
• Commonwealth Hematology-Oncology, P.C.: collaborator

Study Sites (1)

Commonwealth Hematology-Oncology, P.C.

Lawrence, Massachusetts, 01841-2310, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital 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; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedro M Sanz-Altamira, MD, PhD

  Commonwealth Hematology-Oncology, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 17, 2013
• Study Start: September 30, 2013
• Primary Completion: January 28, 2014
• Study Completion: August 26, 2016
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)