Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901351
Status:
RECRUITING
Last Update Posted:
2022-07-21
First Post:
2021-05-20
Brief Title:
Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEP-HPV
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None