Long-term risk assessment of vaginal intraepithelial neoplasia in patients with cervical neoplasia
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)
This study is trying to see how different types of HPV affect the long-term risk of developing vaginal changes in women who have had cervical issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT05931354 on ClinicalTrials.gov |
What this trial studies
This observational study aims to construct a longitudinal risk model for vaginal intraepithelial neoplasia (VAIN) based on the distribution of human papillomavirus (HPV) types in patients with a history of cervical intraepithelial neoplasia (CIN2+). It will include three arms to gather follow-up data from a previous cohort while also prospectively recruiting new subjects to enhance the sample size. The study addresses the lack of long-term outcome data for patients with antecedent CIN and aims to better understand the relationship between HPV and VAIN progression.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 20 years and older with a previous history of CIN.
Not a fit: Patients without a history of cervical intraepithelial neoplasia or those under 20 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the risk factors for VAIN, potentially leading to improved screening and management strategies for affected patients.
How similar studies have performed: While there have been limited studies on VAIN, this approach is novel in constructing a longitudinal risk model specifically for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>= 20 years 2. Those with a previous history of CIN+
Where this trial is running
Taoyuan City
- Chang Gung Medical Foundation — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Lan-Yan Yang, PhD
- Email: lyyang0111@gmail.com
- Phone: 88633281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.