Clinical trial NCT02665299: Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy
Official title: Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for the Detection of Colon Cancer in Patients Undergoing Diagnostic Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Colon Adenomas
Colon Polyps
Keywords: colon cancer
colon polyps
colon adenomas
colonoscopy
circulating tumor DNA
Lead sponsor: Pathway Genomics
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Utility of plasma ctDNA measurements to detect colon cancer or precancerous conditions.
timeFrame: 1 year
Secondary outcomes:
measure: Determination of incident rate of new colon or other cancers in patients who underwent initial measurement of ctDNA
timeFrame: 5 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pathway Genomics
state: California
Study officials:
affiliation: Pathway Genomics
name: Glenn D Braunstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrone F, Lampis A, Bertan C, Verderio P, Ciniselli CM, Pizzamiglio S, Frattini M, Nucifora M, Molinari F, Gallino G, Gariboldi M, Meroni E, Leo E, Pierotti MA, Pilotti S. Circulating free DNA in a screening program for early colorectal cancer detection. Tumori. 2014 Mar-Apr;100(2):115-21. doi: 10.1177/030089161410000201.