Collection of Blood Specimens for Circulating Tumor Cell Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01943500

Enrollment

Registered

2013-09-17

Start date

2013-09-30

Completion date

2016-08-26

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Prostate Cancer

Keywords

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

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.	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.

Countries

United States

Outcome results