Longitudinal HPV Pap in CIN and VAIN

Recruiting

• Conditions: Vaginal Intraepithelial Neoplasia; Hysterectomy; Human Papillomavirus; Cervical Intraepithelial Neoplasia
• Interventions: Other: HPV test and Pap Smear

• Registration Number: NCT05931354
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+. The study will include three arms to complete the follow-up data for the previous cohort constructed, and prospectively recruit new subjects with the appropriate inclusion/excluding criteria in order to increase sample size of this study.

Detailed Description

The long-term outcomes of patients with antecedent cervical intraepithelial neoplasia (CIN) were lacking. A systematic review published in 2008 identified no studies that met the review eligibility criteria for the prevalence of HPV types among vaginal precursors and cancers. Two sporadic studies containing 16 and 81 cases were reported in that review. Given that vaginal intraepithelial neoplasia (VAIN) post-hysterectomy for CIN is an uncommon disease which has a prevalence of being 1 to 6 %; it has the potential to progress to malignancy. Although the etiology of VAIN has not been as thoroughly investigated as that of CIN, evidence implicates that the human papillomavirus (HPV) as the probable carcinogenic agent for the onset and evolution of some VAIN and vaginal cancers.

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

1. Age >= 20 years
2. Those with a previous history of CIN+

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIN_Group	HPV test and Pap Smear	Those with a previous history of cervical cancer or CIN before incident VaIN and those with VaIN detected concomitantly with cervical cancer or CIN for whom both vaginal biopsy and cervical specimens were available in our hospital were eligible.

Primary Outcome Measures

Name	Time	Method
progression rate of CIN+ or VaIN+	5 years	time to developing CIN+ or VaIN+ from first CIN+ diagnosis

Trial Locations

Locations (1)

Chang Gung Medical Foundation; 🇨🇳 Taoyuan City, Taiwan