Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology (DEP-HPV)

Feasibility of a Multi-site Screening Strategy in HPV+ Patients at High Risk of Cancer, With Characterization of the HPV Subtypes Involved by High Throughput Sequencing Technique: DEP-HPV

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.

Study Overview

• Status: Recruiting
• Conditions: Human Papillomavirus
• Intervention / Treatment: Procedure: Smear

Detailed Description

Screening for cervical cancer (CCU) is based on a well-codified, organized national screening program. However, unlike breast cancer or colorectal cancer, there is no personalized screening for patients said identified to be at higher risk of developing UCC. In addition, other cancers linked to HPV (papillomavirus), oropharynx and anal, were excluded from this screening, including for high-risk patients. However, in France, HPV-related cancers in the majority of cases concern the cervix (44%), but the anal (24%) and oropharynx (22%) locations can no longer be neglected. An increase of more than 200% in the incidence of oropharyngeal cancer was reported in the United States between 1988 and 2004. There appears to be a significant association between certain some sexual habits and the risk of multi-site HPV (+) carcinoma. However, several studies suggested that multi-site transmission could involve simple self-inoculation. Therefore, the investigators are interested in a population particularly at risk of developing these viro-induced cancers: patients chronically infected with HPV who will also be those likely to develop multi-site lesions. It is established that high risk HPV are more widely involved in CCU, however, the causes of the persistence of these HPV have not been clearly identified.

It therefore seems essential to continue screening for CCU in chronically infected patients, taking into account the multiple possible locations. The characterization of HPV viruses in terms of types, subtypes and co-infections is one of the key elements, determining the risk of persistence and the risk of cancer. Also, the implementation of a multi-site screening associated with a genotyping by high throughput or new generation sequencing (NGS) would make it possible to understand the part of HPV in the persistence of the infection and to detect the development of lesions at other anatomical sites.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie Chantalat, MD; Phone Number: +33 5.61.32.37.51; Email: chantalat.e@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Elodie CHANTALAT; Email: Chantalat.e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients ≥ 18 years old
• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients chronically infected with HPV; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Elodie Chantalat, MD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cervical cancer; Next generation sequencing; ENT cancer; Anal cancer
• Other Study ID Numbers: RC31/21/0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No