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

Recruiting

• Conditions: cancer of the large bowel; colorectal cancer; 10017990

• Registration Number: NL-OMON31896
• Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 410

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 < 50 year or ii) ³ 2 FDR with CRC diagnosed between 50-70 year or iii) 1 FDR and 1 second degree relative with CRC diagnosed < 70 year.
3) CRC patients
Patients diagnosed with CRC, visiting the *emergency outpatient clinic* of the Division of Gastroenterology-Hepatology after the initial diagnosis of CRC and before subsequent therapeutic interventions are started, will be included.
Additionally, a subset of patients diagnosed with either oesophageal, gastric or pancreatic cancer will be included at our *emergency outpatient clinic* of the Division of Gastroenterology-Hepatology after initial diagnosis and before subsequent therapeutic interventions are started. We will include 20 patients for each group of non-colorectal gastrointestinal malignancy.

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Test characteristics (sensitivity, specificity, positive predictive value,<br /><br>negative predictive value and diagnostic accuracy) of different molecular and<br /><br>protein markers in the detection of colorectal neoplasia in patients with a<br /><br>low-risk or high-risk for CRC. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The identification of risk factors for colorectal neoplasia in subjects at<br /><br>low-risk and at high-risk for CRC. Subsequently, a multi-marker approach for<br /><br>risk stratification in these groups of individuals at different risks for CRC<br /><br>will be designed.</p><br>