Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy

August 16, 2017 updated by: Pathway Genomics

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for the Detection of Colon Cancer in Patients Undergoing Diagnostic Colonoscopy

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. It has also been found in the circulation of some patients with early stage cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. The results of this study should help define the role of ctDNA in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign diseases or no abnormalities).

Study Overview

Status

Completed

Conditions

Detailed Description

After the participants have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to their scheduled screening or diagnostic colonoscopy. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their primary care physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of colon or other cancer.

Study Type

Observational

Enrollment (Actual)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Pathway Genomics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals 18 years of age or older without a prior diagnosis of cancer who are scheduled to undergo a screening or diagnostic colonoscopy by Dr. Phillip Fleshner.

Description

Inclusion Criteria: .

  • 18 years of age or older who are scheduled to undergo a screening or diagnostic colonoscopy by Dr. Phillip Fleshner

Exclusion Criteria:

  • Prior history of cancer excluding basal cell carcinoma of the skin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of plasma ctDNA measurements to detect colon cancer or precancerous conditions.
Time Frame: 1 year
Correlation between plasma ctDNA results and any pathology found at time of diagnostic colonoscopy. Determination of true positive, false positive and predictive values for using ctDNA measurements to detect colon cancer and precancerous conditions.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of incident rate of new colon or other cancers in patients who underwent initial measurement of ctDNA
Time Frame: 5 years
Subjects will be contacted yearly to obtain follow-up information regarding the development of colon or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pathway Genomics

Investigators

  • Principal Investigator: Glenn D Braunstein, MD, Pathway Genomics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pathway Genomics 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with the participants and their primary care physician

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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