Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology (DEP-HPV)
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|ClinicalTrials.gov Identifier: NCT04901351|
Recruitment Status : Not yet recruiting
First Posted : May 25, 2021
Last Update Posted : May 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus||Procedure: Smear||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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) ]
- Number of sites sampled [ Time Frame: Inclusion day (day 0) ]It will be collected anonymously if spontaneously explained by the patient.
- Reasons for refusing multi-site samples [ Time Frame: Inclusion day (day 0) ]
- Positivity to HPV tests for at least one of the other sites (ENT or anal) [ Time Frame: Inclusion day (day 0) ]
- Identification of HPV + subtypes on the different sites [ Time Frame: Inclusion day (day 0) ]
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 ClinicalTrials.gov identifier (NCT number): NCT04901351
|Contact: Elodie Chantalat, MD||188.8.131.52.51 ext +firstname.lastname@example.org|
|Contact: Elodie Chantalat email@example.com|
|Principal Investigator:||Elodie Chantalat, MD||CHU Toulouse|