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Longitudinal HPV Pap in CIN and VAIN

Longitudinal Study of Human Papillomavirus (HPV) Genotyping and Pap Smear in Patients With Antecedent Cervical Intraepithelial Neoplasia (CIN) and Association With Vaginal Intraepithelial Neoplasia (VAIN)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05931354
Acronym
LHPCV
Enrollment
600
Registered
2023-07-05
Start date
2017-07-01
Completion date
2024-06-30
Last updated
2023-07-05

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

Conditions

Cervical Intraepithelial Neoplasia, Human Papillomavirus, Hysterectomy, Vaginal Intraepithelial Neoplasia

Keywords

Cervical Intraepithelial Neoplasia, hysterectomy, human papillomavirus, vaginal intraepithelial neoplasia

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+.

Interventions

OTHERHPV test and Pap Smear

HPV test and Pap Smear

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
progression rate of CIN+ or VaIN+5 yearstime to developing CIN+ or VaIN+ from first CIN+ diagnosis

Countries

Taiwan

Contacts

Primary ContactLan-Yan Yang, PhD
lyyang0111@gmail.com88633281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026