Cervical CancerINDIGONCT06527456
Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
A study testing participation of the general practitioner in people with Cervical Cancer, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year. Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- participation of the general practitioner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2026to Aug 2027
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman aged 25 to 65 living in Ile-De-France
- Eligible for DOCCU (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix)
- Having declared the investigating general practitioner as a treating physician (MT) and whose MT practices in the territory of a CPTS in the UPEC area
- Affiliate to a social security scheme or beneficiary of such a scheme
Who cannot join
- Patient already included in a study on DOCCU
- Patient excluded from organized screening (cervical cancer, hysterectomy).
- Patient's opposition to participating in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Médecins généralistes dans le bassin de l'UPEC
Créteil
Emilie FERRAT, phD, emilie.ferrat@u-pec.fr
About this study
In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.
Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.
Read more
This program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.
The intervention of the general practitioner, an essential player in prevention, could allow for better awareness.
The objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.
Read the detailed description
This is a cluster-randomized trial. Randomization will be performed at the GP practice level to limit the potential contamination bias between doctors within the same practice. GP practices will be randomized either to the 'usual practice' arm or the 'intervention' arm."
If they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, SMS, email, etc.), to encourage her to make an appointment to carry out the screening. Contact arrangements are left to the discretion of each general practitioner..
If they are in the "Usual practice" group, they will use their usual practices to encourage screening.
- Conditions
- Cervical Cancer
- Being tested
- participation of the general practitioner
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participation of the general practitionerOther
participation of the general practitioner in encouraging cervical cancer screening
| Study group | Role | What they receive |
|---|---|---|
| usual practice | No intervention | the doctor will use their usual practices to encourage screening. |
| Intervention | Experimental | the general practitioner or one of the professionals on their team will contact the patient (phone call, SMS, email, etc.), to encourage them to make an appointment to carry out the screening Receives: Other: participation of the general practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening participation rate
percentage of patients who had a screening Cervical Sample (cytology or HPV test within a timeframe satisfying the HAS recommendations according to age) among patients eligible for screening aged 25 to 65 years
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start21 Jan 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527456
- Sponsor's protocol ID
- INDIGO
- Acronym
- INDIGO
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT06527456
- Acronym / sponsor ID
- INDIGO / INDIGO
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.
Since 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.
This program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.
The intervention of the general practitioner, an essential player in prevention, could allow for better awareness.
The objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.
Detailed description
This is a cluster-randomized trial. Randomization will be performed at the GP practice level to limit the potential contamination bias between doctors within the same practice. GP practices will be randomized either to the 'usual practice' arm or the 'intervention' arm."
If they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, SMS, email, etc.), to encourage her to make an appointment to carry out the screening. Contact arrangements are left to the discretion of each general practitioner..
If they are in the "Usual practice" group, they will use their usual practices to encourage screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual practice | No intervention | –the doctor will use their usual practices to encourage screening. |
| Intervention | Experimental | Other: participation of the general practitionerthe general practitioner or one of the professionals on their team will contact the patient (phone call, SMS, email, etc.), to encourage them to make an appointment to carry out the screening |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman aged 25 to 65 living in Ile-De-France
- Eligible for DOCCU (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix)
- Having declared the investigating general practitioner as a treating physician (MT) and whose MT practices in the territory of a CPTS in the UPEC area
- Affiliate to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (3 listed)
- Patient already included in a study on DOCCU
- Patient excluded from organized screening (cervical cancer, hysterectomy).
- Patient's opposition to participating in the study
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 |
|---|---|---|
| participation of the general practitionerparticipation of the general practitioner in encouraging cervical cancer screening | Other | Intervention |
Primary outcome
screening participation rate
Time frame: 12 month
percentage of patients who had a screening Cervical Sample (cytology or HPV test within a timeframe satisfying the HAS recommendations according to age) among patients eligible for screening aged 25 to 65 years
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 14 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing participation of the general practitioner in people with Cervical Cancer, run by Centre Hospitalier Intercommunal Creteil 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: looking for participants now, as of the sponsor's last update on 14 Apr 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?
Contact Emilie FERRAT (0633085225, emilie.ferrat@u-pec.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening participation rate (time frame: 12 month). 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 14 Apr 2026.