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

Human Papillomavirus Clinical Trial

— DEP-HPV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04901351
• Other study ID #: RC31/21/0009
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Toulouse
• Contact: Elodie Chantalat, MD
• Phone: 5.61.32.37.51
• Email: chantalat.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of sites sampled	It will be collected anonymously if spontaneously explained by the patient.	Inclusion day (day 0)
Primary	Reasons for refusing multi-site samples		Inclusion day (day 0)
Secondary	Positivity to HPV tests for at least one of the other sites (ENT or anal)		Inclusion day (day 0)
Secondary	Identification of HPV + subtypes on the different sites		Inclusion day (day 0)