Colorectal CancerEXPEDITNCT06032338
Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering
A study testing CRC screening invitation not including the screening test., Mailing of FIT with invitation and Information letter before invitation in people with Colorectal Cancer, run by University Hospital, Caen at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CRC screening invitation not including the screening test., Mailing of FIT with invitation and Information letter before invitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2023to 14 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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]
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.
Read more
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
- Colorectal Cancer
- Being tested
- CRC screening invitation not including the screening test., Mailing of FIT with invitation, Information letter before invitation
- Keywords
- Screening, Participation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 invitationOther
The invitation to CRC-PBOSP will contain the CRC screening test.
Information letter before invitationOther
An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.
| Study group | Role | What they receive |
|---|---|---|
| Control "C" | Other | 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. Receives: Other: CRC screening invitation not including the screening test. |
| Intervention "B1" | Experimental | 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. Receives: Other: Mailing of FIT with invitation |
| Intervention "B2" | Experimental | 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. Receives: Other: Mailing of FIT with invitation; Other: Information letter before invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation to CRC screening program
Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.
Measured: 16 months after the invitation
Performance of colonoscopy in FIT positive patients
Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
Measured: 6 months after the positive FIT
Secondary outcomes (7)
Participation to CRC screening program at 24 months
Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.
Measured: 24 months after invitation
Time to screening participation
Time to screening participation within 24 months of invitation among invitees
Measured: 24 months after invitation
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
Measured: 12 months after the positive test
Time to colonoscopy (in FIT positive patients)
Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT
Measured: 12 months after the positive test
Colonoscopy findings
Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT
Measured: 12 months after the positive test
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)
Measured: 16 months after invitation
Cost-effectiveness analysis
Costs of CSC-PBOSP from invitation to colonoscopy when necessary
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start14 Sep 2023
- Primary completion14 Apr 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032338
- Sponsor's protocol ID
- 2022-A01914-39
- Acronym
- EXPEDIT
- Status last verified
- Feb 2026
- First submitted
- 20 Jul 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT06032338
- Acronym / sponsor ID
- EXPEDIT / 2022-A01914-39
- Conditions
- Colorectal Cancer
- Keywords
- Screening, Participation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control "C" | Other | Other: CRC screening invitation not including the screening test.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. |
| Intervention "B1" | Experimental | Other: Mailing of FIT with invitationFIT 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. |
| Intervention "B2" | Experimental | Other: Mailing of FIT with invitation, Other: Information letter before invitationFIT 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control "C" |
| Mailing of FIT with invitationThe invitation to CRC-PBOSP will contain the CRC screening test. | Other | Intervention "B1", Intervention "B2" |
| Information letter before invitationAn information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit. | Other | Intervention "B2" |
Primary outcome
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.
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
7 secondary outcomes
Participation to CRC screening program at 24 months
Time frame: 24 months after invitation
Time to screening participation
Time frame: 24 months after invitation
Colonoscopy in FIT positive patients, 12 months after the positive test
Time frame: 12 months after the positive test
Time to colonoscopy (in FIT positive patients)
Time frame: 12 months after the positive test
Colonoscopy findings
Time frame: 12 months after the positive test
Participation to CRC screening program in first invitees (50-51 yrs-old)
Time frame: 16 months after invitation
Cost-effectiveness analysis
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRC screening invitation not including the screening test., Mailing of FIT with invitation and Information letter before invitation in people with Colorectal Cancer, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation to CRC screening program (time frame: 16 months after the invitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.