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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04901351
Recruitment Status : Not yet recruiting
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Procedure: Smear Not Applicable

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%), in the majority of cases, 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, we 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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. [ Time Frame: Inclusion day (day 0) ]
  2. Number of sites sampled [ Time Frame: Inclusion day (day 0) ]
    It will be collected anonymously if spontaneously explained by the patient.

  3. Reasons for refusing multi-site samples [ Time Frame: Inclusion day (day 0) ]

Secondary Outcome Measures :
  1. Positivity to HPV tests for at least one of the other sites (ENT or anal) [ Time Frame: Inclusion day (day 0) ]
  2. Identification of HPV + subtypes on the different sites [ Time Frame: Inclusion day (day 0) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04901351

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Contact: Elodie Chantalat, MD ext +33

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CHU Toulouse
Toulouse, France
Contact: Elodie Chantalat   
Sponsors and Collaborators
University Hospital, Toulouse
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Principal Investigator: Elodie Chantalat, MD CHU Toulouse
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Responsible Party: University Hospital, Toulouse Identifier: NCT04901351    
Other Study ID Numbers: RC31/21/0009
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Cervical cancer
Anal cancer;
ENT cancer
Next generation sequencing