Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Colorectal Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2017 |
| Start Date: | January 2016 |
| End Date: | December 2020 |
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).
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).
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.
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.
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
We found this trial at
1
site
San Diego, California 92121
Principal Investigator: Glenn Braunstein, MD
Phone: 866-960-9131
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