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Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665299
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Pathway Genomics

Tracking Information
First Submitted Date January 22, 2016
First Posted Date January 27, 2016
Last Update Posted Date August 21, 2017
Study Start Date January 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02665299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 22, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood is drawn and DNA is purified from the plasma. The DNA is analyzed for circulating tumor DNA. The DNA will be stored for up to 10 years.
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.
Condition
  • Colon Cancer
  • Colon Adenomas
  • Colon Polyps
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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: 10.1700/1491.16389.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 16, 2017)
206
Original Estimated Enrollment
 (submitted: January 22, 2016)
200
Actual Study Completion Date August 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02665299
Other Study ID Numbers Pathway Genomics 005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data will be shared with the participants and their primary care physician
Responsible Party Pathway Genomics
Study Sponsor Pathway Genomics
Collaborators Not Provided
Investigators
Principal Investigator: Glenn D Braunstein, MD Pathway Genomics
PRS Account Pathway Genomics
Verification Date August 2017