CELTiC trial: an international multicentre study evaluating the CELTiC panel for the detection of advanced neoplasia in Feacal Immunochemical Test (FIT)-positive individuals

CELTiC trial: an international multicentre study evaluating the CELTiC panel for the detection of advanced neoplasia in Feacal Immunochemical Test (FIT)-positive individuals - CELTiC trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50791

Enrollment

320

Registered

2021-06-11

Start date

2021-08-03

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Advanced neoplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Individuals with a positive FIT test in the national CRC screening program of the Netherlands and Italy, between 55 and 75 years old (Netherlands), or 50 and 69 years old (Italy).

Exclusion criteria

Exclusion criteria: Individuals with Inflammatory Bowel Disease, under current treatment of colorectal cancer, or under current endoscopic surveillance.

Design outcomes

Primary

Measure	Time frame
Primary: sensitivity of the CELTiC panel for detecting advanced neoplasia at a threshold with an expected sensitivity of 90%;	—

Secondary

Measure	Time frame
Secondary: specificity and positive predictive value of the CELTiC panel for detecting advanced neoplasia at a threshold with an expected sensitivity of 90%; specificity and positive predictive value of the CELTiC panel for detecting advanced neoplasia at a threshold with an observed sensitivity of 90%; C-statistic of the CELTiC panel; association between CELTiC score and FIT concentration.	—

Countries

Netherlands

Outcome results