NCT06527456

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Aug 2027

First Submitted

Initial submission to the registry

October 20, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

October 20, 2023

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    12 month

Study Arms (2)

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

Other: participation of the general practitioner

Interventions

participation of the general practitioner in encouraging cervical cancer screening

Intervention

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient already included in a study on DOCCU
  • Patient excluded from organized screening (cervical cancer, hysterectomy).
  • Patient's opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecins généralistes dans le bassin de l'UPEC

Créteil, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

July 30, 2024

Study Start

January 21, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-03

Locations