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

NCT06032338 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64000

Last updated 2026-03-18

No results posted yet for this study

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).

Conditions

Interventions

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.

OTHER

Mailing of FIT with invitation

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

OTHER

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.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire

    collaborator UNKNOWN

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2026-04-14
Completion
2026-11-14

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032338 on ClinicalTrials.gov