Clinical trial · Interventional
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
NCT02780960CI-TRIAL-00049809completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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+.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intra-epithelial Neoplasia Grade 1 or Worse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV self-testing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV self-testing
- description
- 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.
- interventionNames
- Device: HPV self-testing
Primary outcomes (1)
- measure
- Number of patients with CIN
- timeFrame
- 12 months
- description
- Number of patients with CIN after LEEP.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDViviano 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. PMID 34976630