Longitudinal HPV Pap in CIN and VAIN

Last updated: June 27, 2023
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Genitourinary Cancer

Cervical Intraepithelial Neoplasia

Treatment

HPV test and Pap Smear

Clinical Study ID

NCT05931354
201700471B0
  • Ages > 20
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >= 20 years

  2. Those with a previous history of CIN+

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: HPV test and Pap Smear
Phase:
Study Start date:
July 01, 2017
Estimated Completion Date:
June 30, 2024

Study 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+.

Connect with a study center

  • Chang Gung Medical Foundation

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

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