Evaluation of novel serological markers for early diagnosis of colorectal neoplasia

• Conditions: C18; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum; C19; C20

• Registration Number: DRKS00003095
• Lead Sponsor: Deutsches Krebsforschungszentrum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-24
• Study Completion: 2014-09-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2045

Inclusion Criteria

participants in screening colonoscopy, age 55-75, women, men, informed consent

Exclusion Criteria

colonoscopy due to symptoms or a preceding positive colorectal cancer screening test, endoscopic examination of large bowel (colonoscopy, sigmoidoscopy) within the preceding 5 years, incomplete screening colonoscopy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity of the three serological tests at predefined cutpoints with colonoscopy as gold standard for ascertainment of colorectal neoplasia

Secondary Outcome Measures

Name	Time	Method
positive and negative predictive values, ROC curve and its area under the curve (AUC), likelihood ratios, number needed to screen