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Identification of DNA methylation markers for plasma-based detection of advanced colorectal adenomas.

Withdrawn
Conditions
10017987
10017934
sporadic advanced colorectal adenoma
sporadic high-risk colorectal polyps
Registration Number
NL-OMON41939
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
371
Inclusion Criteria

- >45 years
- scheduled for screening colonoscopy or subsequent polypectomy. Indications for screening colonoscopy are rectal blood loss, anemia, change in bowel habits, positive iFOBT or positive family history of adenomas or CRC (two or more first degree relatives or one or more at age 50 years or less).

Exclusion Criteria

- having hereditary colorectal cancer syndrome (e.g. Lynch syndrome or polyposis syndromes) or suspicion thereof
- having inflammatory bowel disease
- previous adenoma
- cancer within the past five years
- colonoscopy that is incomplete or associated with a poor preparation
- lack of histological classification of polyps removed at screening colonoscopy

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Difference in DNA methylation of a certain adenoma subtype and normal mucosa of<br /><br>controls.<br /><br>Difference in cfDNA methylation of screening colonoscopy patients with advanced<br /><br>adenoma and those found to be free of colorectal polyps/cancer and<br /><br>inflammation. .</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Difference in DNA methylation of a certain adenoma subtype and leucocytes of<br /><br>controls, (pre)malignant tissue from cancer other than CRC or inflammatory<br /><br>conditions, or non-advanced polyps.<br /><br>Difference in cfDNA methylation of screening colonoscopy patients with advanced<br /><br>adenoma and those with non-advanced polyps.</p><br>
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