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

HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02780960
Enrollment
127
Registered
2016-05-24
Start date
2016-05-31
Completion date
2020-10-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intra-epithelial Neoplasia Grade 1 or Worse

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.

Interventions

DEVICEHPV self-testing

Patients will perform HPV testing themselves at home.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with CIN12 monthsNumber of patients with CIN after LEEP.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026