Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering

Colorectal Cancer Clinical Trial

— EXPEDIT  

Official title:

EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032338
• Other study ID #: 2022-A01914-39
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: November 14, 2026

Study information

• Verified date: July 2023
• Source: University Hospital, Caen
• Contact: Lydia GUITTET, MD,PhD
• Phone: +33(0)231065781
• Email: guittet-l[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP). In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study. Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test: - Method "B1": invitation with test sent to home without prior information letter - Method "B2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time. Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64000
• Est. completion date: November 14, 2026
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• 50 to 74 years old
• Resident of Centre Val de Loire French area
• Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period
• Affiliated to the health insurance scheme

Exclusion Criteria:

• CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease)
• Colonoscopy in the previous 5 years) Subjects refusing data transmission to research team will be excluded from statistical analyses.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• CRC screening invitation not including the screening test.
The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
• Mailing of FIT with invitation
The invitation to CRC-PBOSP will contain the CRC screening test.
• Information letter before invitation
An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.

Locations

Country	Name	City	State
France	Crcdc-Cvl	Tours

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation to CRC screening program	Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.	16 months after the invitation
Primary	Performance of colonoscopy in FIT positive patients	Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT	6 months after the positive FIT
Secondary	Participation to CRC screening program at 24 months	Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.	24 months after invitation
Secondary	Time to screening participation	Time to screening participation within 24 months of invitation among invitees	24 months after invitation
Secondary	Colonoscopy in FIT positive patients, 12 months after the positive test	Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT	12 months after the positive test
Secondary	Time to colonoscopy (in FIT positive patients)	Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT	12 months after the positive test
Secondary	Colonoscopy findings	Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT	12 months after the positive test
Secondary	Participation to CRC screening program in first invitees (50-51 yrs-old)	Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)	16 months after invitation
Secondary	Cost-effectiveness analysis	Costs of CSC-PBOSP from invitation to colonoscopy when necessary	24 months