Clinical trial · Observational
Screening and Risk Factors of Colon Neoplasia
NCT01647776CI-TRIAL-00049953completedClinicalTrials.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 investigators propose a screening population-based study to systematically evaluate the accuracy and clinical relevance of sDNA testing as a potential alternative to colonoscopy screening. In addition, the investigators propose a genetic epidemiologic study of the relation between colon polyps, an established precursor of colon cancer, and two factors that may influence risk for colon cancer: candidate genes and diet.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsies of rectal and colon mucosa | Procedure | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Stool DNA Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Individuals without colon polyps
- interventionNames
- Other: Stool DNA Test
- Procedure: biopsies of rectal and colon mucosa
- Other: Questionnaires
- label
- Individuals with colon polyps
- interventionNames
- Other: Stool DNA Test
- Procedure: biopsies of rectal and colon mucosa
- Other: Questionnaires
Primary outcomes (2)
- measure
- Stool DNA (sDNA) Feasibility and Compliance
- timeFrame
- within 12 weeks prior to the colonoscopy
- description
- For this aim, we will recruit a sub-sample of the study participants to perform the sDNA test for aberrantly methylated markers in addition to their colonoscopy to assess willingness to participate, compliance with test protocol and patient satisfaction to determine potential for a larger study to evaluate the effectiveness of this test for detection of colon adenomas.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio Exclusion Criteria: * Unable to give written consents * Unable to fill the questionnaires * A history of polyps within the past 10 years (except hyperplastic polyps) * Family history of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC) * Personal history of inflammatory bowel disease * Personal diagnosis of any cancer, with the exception of non-melanoma skin cancer * Any major colon surgeries (e.g. resectioning)
References
Publications (0)
Data not yet available
No reference posted for this study.