Clinical trial · Interventional
Colonoscopic Removal of Aberrant Crypt Foci: a Prospective, Randomized, Blinded Trial
Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
NCT00623883CI-TRIAL-00001165completedN/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)
We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopic evaluation only | Procedure | — | UNRESOLVED |
| Surgical removal of ACF | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- All identified ACF eliminated by cold or hot colonoscopic biopsy forceps
- interventionNames
- Procedure: Surgical removal of ACF
- type
- SHAM_COMPARATOR
- label
- 2
- description
- ACF quantified and observed, re-evaluated after one year
- interventionNames
- Procedure: Colonoscopic evaluation only
Primary outcomes (1)
- measure
- number, size, and location of ACF identified
- timeFrame
- initially and after one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Dept.of Defense Healthcare Beneficiaries 2. Age 18 or over, non-pregnant 3. History of colorectal cancer or other indication for colonoscopic screening 4. At least half of large intestine remaining 5. No use of investigational or chemotherapeutic drugs within 6 mos. - Exclusion Criteria: 1. History suggesting familial colon cancer syndrome 2. \< 6 mos since colon resection or since treatment for colon cancer 3. Anticipated colon surgery within one year of entry 4. Inability to participate in scheduled followup at one year 5. Medical or psychiatric condition which would make patient a poor candidate -
References
Publications (2)
- RESULTGlebov OK, Rodriguez LM, Soballe P, DeNobile J, Cliatt J, Nakahara K, Kirsch IR. Gene expression patterns distinguish colonoscopically isolated human aberrant crypt foci from normal colonic mucosa. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2253-62. doi: 10.1158/1055-9965.EPI-05-0694. PMID 17119054
- RESULTGlebov OK, Rodriguez LM, Nakahara K, Jenkins J, Cliatt J, Humbyrd CJ, DeNobile J, Soballe P, Simon R, Wright G, Lynch P, Patterson S, Lynch H, Gallinger S, Buchbinder A, Gordon G, Hawk E, Kirsch IR. Distinguishing right from left colon by the pattern of gene expression. Cancer Epidemiol Biomarkers Prev. 2003 Aug;12(8):755-62. PMID 12917207