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NCT Number: NCT06032338

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Crcdc-Cvl

Tours, 37000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRC screening invitation not including the screening test.

Other

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

Mailing of FIT with invitation

Other

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

Information letter before invitation

Other

An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.

Primary outcomes

  1. Participation to CRC screening program

    Time frame: 16 months after the invitation

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

  2. Performance of colonoscopy in FIT positive patients

    Time frame: 6 months after the positive FIT

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

Secondary outcomes

  1. Participation to CRC screening program at 24 months

    Time frame: 24 months after invitation

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

  2. Time to screening participation

    Time frame: 24 months after invitation

    Time to screening participation within 24 months of invitation among invitees

  3. Colonoscopy in FIT positive patients, 12 months after the positive test

    Time frame: 12 months after the positive test

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

  4. Time to colonoscopy (in FIT positive patients)

    Time frame: 12 months after the positive test

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

  5. Colonoscopy findings

    Time frame: 12 months after the positive test

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

  6. Participation to CRC screening program in first invitees (50-51 yrs-old)

    Time frame: 16 months after invitation

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

  7. Cost-effectiveness analysis

    Time frame: 24 months

    Costs of CSC-PBOSP from invitation to colonoscopy when necessary

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study 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]

Acronym: EXPEDIT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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