Collection of Blood Specimens for Circulating Tumor Cell Analysis

NCT ID: NCT01943500

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-08-26

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer Prostate Cancer Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cancer or no prior history of cancer

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Commonwealth Hematology-Oncology, P.C.

UNKNOWN

Sponsor Role collaborator

Viatar LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro M Sanz-Altamira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Commonwealth Hematology-Oncology, P.C.

Locations

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Commonwealth Hematology-Oncology, P.C.

Lawrence, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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T30-0001

Identifier Type: -

Identifier Source: org_study_id

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