Clinical trial · Interventional
Cell-free DNA Methylation Markers for Cancer Screening
NCT03096938CI-TRIAL-00030915unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the role of cell-free DNA methylation markers in cancer screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylation markers screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Normal screening group
- description
- patients receive the routine screening examination
- interventionNames
- Diagnostic Test: methylation markers screening
- type
- EXPERIMENTAL
- label
- methylation markers screening group
- description
- patients receive the methylation markers screening
- interventionNames
- Diagnostic Test: methylation markers screening
Primary outcomes (2)
- measure
- sensitivity (true positive rate)
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is average risk for development of cancer 2. Subject able and willing to undergo screening test within 90 days of enrollment 3. Subject is 40 to 74 years of age inclusive 4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study Exclusion Criteria: 1. Subject has any condition which, in the opinion of the investigator should preclude participation in the study 2. Subject has a history of cancer 3. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.
References
Publications (1)
- RESULTImperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19. PMID 24645800