Longitudinal HPV Pap in CIN and VAIN (LHPCV)

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Vaginal Intraepithelial Neoplasia; Hysterectomy; Cervical Intraepithelial Neoplasia; Human Papillomavirus

Treatments: Other: HPV test and Pap Smear

Study type: Observational

Funder types: Other

Identifiers

NCT05931354

201700471B0

Details and patient eligibility

About

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.

Full 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+.

Enrollment: 600 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

600 participants in 1 patient group

CIN_Group

Description:

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.

Treatment:

Other: HPV test and Pap Smear