Clinical trial · Observational
Prevention and Early Detection Biomarkers of Adenomas and CRC Lesions During CRC Screening
Νew Molecular Biomarkers for the Prevention and Early Detection of Precancerous or Cancerous Colorectal Lesions During Screening for Colorectal Cancer
- 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 designed a prospective study to evaluate the predictive ability of detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras, B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the context of screening under international CRC prevention instructions. This investigation will be carried out in individuals in normal risk in order to study specific mutations (in blood and tissue) to draw reliable conclusions about whether we can detect (with greater sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood test thereby reducing the cost and side effects of repeated endoscopic procedures.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- No pathological findings
- description
- blood and biopsy samples from normal colon mucosa
- label
- >1 cm adenomatous polys
- description
- blood and biopsy samples from the polyp
- label
- Colorectal cancer
- description
- blood (plasma) and biopsy samples from colorectal cancer
Primary outcomes (3)
- measure
- Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings
- timeFrame
- 1 month
- measure
- Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with adenomatous polyp bigger than 1 cm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection Exclusion Criteria: \-
References
Publications (9)
- RESULTFerlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
- RESULTPox CP, Altenhofen L, Brenner H, Theilmeier A, Von Stillfried D, Schmiegel W. Efficacy of a nationwide screening colonoscopy program for colorectal cancer. Gastroenterology. 2012 Jun;142(7):1460-7.e2. doi: 10.1053/j.gastro.2012.03.022. Epub 2012 Mar 21. PMID 22446606
- RESULTDeschoolmeester V, Baay M, Specenier P, Lardon F, Vermorken JB. A review of the most promising biomarkers in colorectal cancer: one step closer to targeted therapy. Oncologist. 2010;15(7):699-731. doi: 10.1634/theoncologist.2010-0025. Epub 2010 Jun 28. PMID 20584808
- RESULTPino MS, Chung DC. The chromosomal instability pathway in colon cancer. Gastroenterology. 2010 Jun;138(6):2059-72. doi: 10.1053/j.gastro.2009.12.065. PMID 20420946
- RESULTBoland CR, Goel A. Microsatellite instability in colorectal cancer. Gastroenterology. 2010 Jun;138(6):2073-2087.e3. doi: 10.1053/j.gastro.2009.12.064. PMID 20420947
- RESULTSchee K, Fodstad O, Flatmark K. MicroRNAs as biomarkers in colorectal cancer. Am J Pathol. 2010 Oct;177(4):1592-9. doi: 10.2353/ajpath.2010.100024. Epub 2010 Sep 9. PMID 20829435
- RESULTShen L, Toyota M, Kondo Y, Lin E, Zhang L, Guo Y, Hernandez NS, Chen X, Ahmed S, Konishi K, Hamilton SR, Issa JP. Integrated genetic and epigenetic analysis identifies three different subclasses of colon cancer. Proc Natl Acad Sci U S A. 2007 Nov 20;104(47):18654-9. doi: 10.1073/pnas.0704652104. Epub 2007 Nov 14. PMID 18003927
- RESULTSoreide K, Janssen EA, Soiland H, Korner H, Baak JP. Microsatellite instability in colorectal cancer. Br J Surg. 2006 Apr;93(4):395-406. doi: 10.1002/bjs.5328.