Personalized HPV screening for patients with chronic high-risk infections
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
NA · University Hospital, Toulouse · NCT04901351
This study is testing a new way to screen patients with long-term high-risk HPV infections to see if taking samples from different body areas can help catch potential cancers earlier.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04901351 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of personalized screening for patients chronically infected with high-risk human papillomavirus (HPV-HR), who are at increased risk of developing cervical and other HPV-related cancers. It focuses on assessing the acceptability of sampling from various anatomical sites, including the ENT and anal regions, for HPV analysis using next-generation sequencing. The study seeks to understand the persistence of HPV infections and the potential for multi-site lesions in these patients, contributing to improved screening protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with persistent high-risk HPV infections or a history of high-grade cervical lesions.
Not a fit: Patients with infections solely linked to low-risk HPV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized screening strategies for patients at high risk of HPV-related cancers.
How similar studies have performed: While personalized screening for HPV-related cancers is an emerging field, this specific approach using next-generation sequencing in multi-site sampling is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -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.
Where this trial is running
Toulouse
- CHU Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Elodie Chantalat, MD — University Hospital, Toulouse
- Study coordinator: Elodie Chantalat, MD
- Email: chantalat.e@chu-toulouse.fr
- Phone: 5.61.32.37.51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Human Papillomavirus, Cervical cancer, Anal cancer, ENT cancer, Next generation sequencing