Can we analyse stool content to improve the prediction of the risk of developing bowel cancer?

Combining faecal biomarkers to improve prediction of individual risk of pre-invasive and invasive colorectal lesions

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10728933

Enrollment

25000

Registered

2022-09-23

Start date

2022-06-01

Completion date

Unknown

Last updated

2022-10-03

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

Conditions

Colorectal advanced neoplasia, advanced adenoma and colorectal cancer Cancer

Interventions

The randomization will be performed within the IT system governing the screening program. Subjects eligible for inclusion in the study will be randomized at the time of sending the FIT result to the s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects at intermediate risk for CRC eligible for invitation to the regional screening program: all residents, aged 59 to 69 years, attending the screening invitation in the Turin and Biella screening programs.

Exclusion criteria

Exclusion criteria: 1. Recent examination (colonoscopy or FIT) 2. Personal or family history of CRC 3. Disabling or terminal illness 4. Unable to provide informed consent 5. Over the age of 64 years at the time of recruitment, who would no longer be eligible for subsequent invitations to screening, which is discontinued for subjects over 69 years of age

Design outcomes

Primary

Measure	Time frame
Measured using patient records: Group a) Advanced neoplasia (AN) detection rate and CRC distribution by colonic site and stage at diagnosis of screen-detected CRCs, measured at the index TC in group 1; cumulative AN yield over two FIT examinations performed at 1-year interval in group 2 and at the second round in group 3. Group b) Positivity rate (PR), positive predictive value (PPV) and AN detection rate, measured at the subsequent screening round in each arm, and CRC distribution by colonic site and stage at diagnosis of screen-detected CRC.	—

Measure

Time frame

Measured using patient records: Group a) Advanced neoplasia (AN) detection rate and CRC distribution by colonic site and stage at diagnosis of screen-detected CRCs, measured at the index TC in group 1; cumulative AN yield over two FIT examinations performed at 1-year interval in group 2 and at the second round in group 3. Group b) Positivity rate (PR), positive predictive value (PPV) and AN detection rate, measured at the subsequent screening round in each arm, and CRC distribution by colonic site and stage at diagnosis of screen-detected CRC.

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Secondary

Measure	Time frame
Measured using patient records: 1. Interval cancer (IC) rate. Interval cancers are identified through analysis of hospital discharge records and population cancer registry data. The rate will be estimated over a 2-year period following a negative FIT. The researchers will use the proportional incidence method to compare the observed to the expected (in the absence of screening) rate. 2. PPV for advanced adenoma (AA) and for CRC of immediate colonoscopy referral and of the positive FIT results, measured as the proportion of subjects detected with the lesion of interest over the total number of subjects undergoing TC.	—

Measure

Time frame

Measured using patient records: 1. Interval cancer (IC) rate. Interval cancers are identified through analysis of hospital discharge records and population cancer registry data. The rate will be estimated over a 2-year period following a negative FIT. The researchers will use the proportional incidence method to compare the observed to the expected (in the absence of screening) rate. 2. PPV for advanced adenoma (AA) and for CRC of immediate colonoscopy referral and of the positive FIT results, measured as the proportion of subjects detected with the lesion of interest over the total number of subjects undergoing TC.

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Countries

Italy

Outcome results

None listed

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