Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

NCT ID: NCT02780960

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-10-31

Brief Summary

The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.

Detailed Description

The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).

Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).

the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.

Conditions

Cervical Intra-epithelial Neoplasia Grade 1 or Worse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HPV self-testing

Patients will perform HPV self-testing at home, prior to their follow-up visit. At the colposcopy visit, the doctor or nurse will also perform HPV testing. This procedure will be repeated at 6 and 12 months following LEEP.

Group Type: EXPERIMENTAL

HPV self-testing

Intervention Type: DEVICE

Patients will perform HPV testing themselves at home.

Interventions

HPV self-testing

Patients will perform HPV testing themselves at home.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• attending colposcopy clinic
• biopsy-proven CIN1+ lesion
• understands study procedures and accepts voluntarily to participate by signing the informed consent form

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Manuela Viviano

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geneva University Hospital

Geneva, , Switzerland

Countries

Switzerland

References

Viviano M, Vassilakos P, Meyer-Hamme U, Grangier L, Emery SL, Malinverno MU, Petignat P. HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country. Prev Med Rep. 2021 Sep 20;24:101564. doi: 10.1016/j.pmedr.2021.101564. eCollection 2021 Dec.

Reference Type: DERIVED

PMID: 34976630 (View on PubMed)

Other Identifiers

15-285

Identifier Type: -

Identifier Source: org_study_id