NCT04901351

Brief Summary

The main risk of developing cervical cancer is the persistence of an High risk human papillomavirus (HPV-HR) infection, the mechanisms of which are still not understood. These chronically infected patients could develop multi-site lesions. The main objective is to assess the feasibility of setting up a personalized screening in patients at high risk of cervical cancer (chronically infected with HPV), by evaluating documenting the acceptability of these patients to be sampled from the ENT sphere and anal spheres for HPV analysis with next-generation sequencing.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

May 20, 2021

Last Update Submit

July 18, 2024

Conditions

Human Papillomavirus

Keywords

Cervical cancerAnal cancer;ENT cancerNext generation sequencing

Outcome Measures

Primary Outcomes (3)

  • Acceptance by the patient (yes / no binary variable) of ENT and / or anal samples in addition to the cervical sample during an annual gynecological follow-up.

    Inclusion day (day 0)

  • Number of sites sampled

    It will be collected anonymously if spontaneously explained by the patient.

    Inclusion day (day 0)

  • Reasons for refusing multi-site samples

    Inclusion day (day 0)

Secondary Outcomes (2)

  • Positivity to HPV tests for at least one of the other sites (ENT or anal)

    Inclusion day (day 0)

  • Identification of HPV + subtypes on the different sites

    Inclusion day (day 0)

Study Arms (1)

Patients chronically infected with HPV

EXPERIMENTAL

The study will be offered to patients with chronic HPV infection as part of an annual consultation scheduled in the gynecology care package.

Procedure: Smear

Interventions

SmearPROCEDURE

In addition to the routine gynecological follow-up including a cervico-vaginal smear and an HPV test (HPV-HR genome detection), the doctor will propose prospectively to all consecutive patients who meet the inclusion criteria, during a follow-up consultation (post treatment of cervical dysplasia), to participate in the study, that is to have 2 other anal and ENT samples for an HPV test

Patients chronically infected with HPV

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic infected patients defined by: Patients with persistent HPV-HR cytological infection (high risk) (as early as 6 months post-treatment of a cervical or vaginal injury), or a recurrence of a high-grade squamous intraepithelial lesion (CIN2 or CIN3 or HSIL) or a recurrence of cancer in the cervix or vagina
  • Patients who have given their written consent to participate in the study.
  • Person affiliated or beneficiary of a social security scheme.

You may not qualify if:

  • Patient with an infection or a persistent lesion after treatment or not, linked only to low-risk HPV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsAnus Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Elodie Chantalat, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie Chantalat, MD

CONTACT

5.61.32.37.51chantalat.e@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

June 21, 2022

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)