Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study.

This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.

FIT mailed at home within the CRC screening invitation without prior information letter.

This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.

FIT mailed at home within the CRC screening invitation with prior information letter.

This arm is suitable for the first screening round in 50-51 years old population only.

The invitation to CRC-PBOSP will only contain informations on how to get the screening test.

CRC screening invitation not including the screening test.

The invitation to CRC-PBOSP will contain the CRC screening test.

Mailing of FIT with 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.

Information letter before invitation

Lydia GUITTET, MD,PhD

Julie BOYARD, ScD

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).

The number of study arms will differ according to age-group:

* In 50 or 51 yrs age-group, individuals (n=5760 ) will be randomised in 3 groups: C, B1 and B2 (allocation ratio 2:1:1)
* In the age-group older than 51 yrs, individuals (n=58240) will be randomised in 2 groups: C, and B1 (allocation 1:1) In the main analysis including both age-groups, B1 and B2 arms would be pooled.

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

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]

Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.

Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT

Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.

Time to screening participation within 24 months of invitation among invitees

Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT

Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT

Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT

Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)

Costs of CSC-PBOSP from invitation to colonoscopy when necessary

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering	NCT06032338	Colorectal Canc...	CRC screening i... Mailing of FIT ... Information let...	50 Years - 74 Years	University Hospital, Caen
Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering	NCT06032338	Colorectal Canc...	CRC screening i... Mailing of FIT ... Information let...	50 Years - 74 Years	University Hospital, Caen

Spots Global Cancer Trial Database for crc screening invitation not including the screening test.