NCT05163236

Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening

Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,149 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 50 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.

Detailed description

Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic accuracy for CRCs than previous screening tests. Determining the incidence of post-test interval CRCs, diagnosed after a negative FIT and before the recommended date of the next test (2-year interval), allows assessment of the sensitivity of the test. The primary objective of this study was to evaluate the performance of FIT during the CRC screening campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its secondary objectives were the evaluation of diagnostic circumstances and their impact on treatment and survival, and risk factors for interval cancer (IC).

Conditions

• Colorectal Neoplasms Malignant
• Colonoscopy
• Early Detection of Cancer
• Female
• Mass Screening
• Middle Aged
• Occult Blood

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Positive fecal immunochemical test (FIT)	We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
DIAGNOSTIC_TEST	Negative fecal immunochemical test (FIT)	We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
DIAGNOSTIC_TEST	Fecal immunochemical test (FIT) not performed	We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.

Timeline

• Start date: 2021-04-20
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2021-12-20
• Last updated: 2021-12-20

Locations

1 site across 1 country: France