Evaluation of novel serological markers for early diagnosis of colorectal neoplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003095

Enrollment

2000

Registered

2011-08-24

Start date

2012-01-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C18 C19 C20

Interventions

Group 1: Observational study: Participants in the colorectal cancer screening program, who undergo colonoscopy and a serological examination.

Eligibility

Sex/Gender

All

Age

55 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactJason Hochhaus

Deutsches Krebsforschungszentrum Heidelberg

j.hochhaus@dkfz.de06221421329

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026