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
1 other identifier
observational
92
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 13, 2019
March 1, 2019
1.9 years
October 3, 2015
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings
1 month
Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with adenomatous polyp bigger than 1 cm
1 month
Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with cancerous lesion
1 month
Study Arms (3)
No pathological findings
blood and biopsy samples from normal colon mucosa
>1 cm adenomatous polys
blood and biopsy samples from the polyp
Colorectal cancer
blood (plasma) and biopsy samples from colorectal cancer
Eligibility Criteria
Individuals in normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection
You may qualify if:
- normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelismos Hospital
Athens, Attica, 10676, Greece
Related Publications (9)
Ferlay 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: 21351269RESULTPox 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: 22446606RESULTDeschoolmeester 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: 20584808RESULTPino 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: 20420946RESULTBoland 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: 20420947RESULTSchee 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: 20829435RESULTShen 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: 18003927RESULTSoreide 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.
PMID: 16555243RESULTBaylin SB, Hoppener JW, de Bustros A, Steenbergh PH, Lips CJ, Nelkin BD. DNA methylation patterns of the calcitonin gene in human lung cancers and lymphomas. Cancer Res. 1986 Jun;46(6):2917-22.
PMID: 3009002RESULT
Biospecimen
whole blood serum and colonic polyps tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikos Viazis, Director
Evangelismos Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Gastroenterology
Study Record Dates
First Submitted
October 3, 2015
First Posted
November 4, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
May 1, 2018
Last Updated
March 13, 2019
Record last verified: 2019-03