Longitudinal HPV Pap in CIN and VAIN (LHPCV)

June 27, 2023 updated by: Chang Gung Memorial Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:
          • Lan-Yan Yang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CIN_Group
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.
Other: HPV test and Pap Smear
HPV test and Pap Smear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression rate of CIN+ or VaIN+
Time Frame: 5 years
time to developing CIN+ or VaIN+ from first CIN+ diagnosis
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201700471B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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