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Trial Title:
Longitudinal HPV Pap in CIN and VAIN
NCT ID:
NCT05931354
Condition:
Cervical Intraepithelial Neoplasia
Hysterectomy
Human Papillomavirus
Vaginal Intraepithelial Neoplasia
Conditions: Official terms:
Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Conditions: Keywords:
Cervical Intraepithelial Neoplasia
hysterectomy
human papillomavirus
vaginal intraepithelial neoplasia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
HPV test and Pap Smear
Description:
HPV test and Pap Smear
Arm group label:
CIN_Group
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+.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age >= 20 years
2. Those with a previous history of CIN+
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Medical Foundation
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Lan-Yan Yang, PhD
Start date:
July 1, 2017
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05931354
