Clinical trial · Observational
Plasma ctDNA in Patients Undergoing Diagnostic Colonoscopy
Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for the Detection of Colon Cancer in Patients Undergoing Diagnostic Colonoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenomas | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyps | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Utility of plasma ctDNA measurements to detect colon cancer or precancerous conditions.
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
- measure
- Determination of incident rate of new colon or other cancers in patients who underwent initial measurement of ctDNA
- timeFrame
- 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDPerrone 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. PMID 24852853