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Non-invasive markers for colorectal neoplasia A multi-marker approach in screening for colorectal cancer

Non-invasive markers for colorectal neoplasia A multi-marker approach in screening for colorectal cancer - Non-invasive markers for colorectal neoplasia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31896
Enrollment
410
Registered
2008-08-29
Start date
2009-05-29
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the large bowel colorectal cancer

Interventions

None listed

Sponsors

Academisch Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects who will undergo a colonoscopy. 1) average-risk population Employees (50-65 years of age) from companies participating in the ongoing workplace-based CRC screening project by colonoscopy have already been included. 2) high-risk population Patients with a positive family history of CRC visiting the *outpatient clinic for hereditary colorectal cancer* or visiting the endoscopy unit of the MUMC+ for surveillance colonoscopy will be asked to participate into the study. This population will include patients with hereditary forms of CRC (Lynch syndrome or FAP) as well as patients fulfilling the criteria for familial CRC syndrome: i) ³ 1 first degree relative (FDR) with CRC diagnosed

Exclusion criteria

Exclusion criteria: Individuals will be excluded if: -younger than 18 years old -diagnosed with inflammatory bowel disease (Crohn*s disease or ulcerative colitis) -diagnosed with major co-morbidity which may interfere with the outcome of the study (e.g. severe cardiovascular or pulmonary disease, other malignancies)

Design outcomes

Primary

MeasureTime frame
Test characteristics (sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy) of different molecular and protein markers in the detection of colorectal neoplasia in patients with a low-risk or high-risk for CRC.

Secondary

MeasureTime frame
The identification of risk factors for colorectal neoplasia in subjects at low-risk and at high-risk for CRC. Subsequently, a multi-marker approach for risk stratification in these groups of individuals at different risks for CRC will be designed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)