LHPCV: Longitudinal HPV Pap in CIN and VAIN

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05931354
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia; Hysterectomy; Human Papillomavirus; Vaginal Intraepithelial Neoplasia	Other: HPV test and Pap Smear

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 Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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)
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. progression rate of CIN+ or VaIN+ [5 years]

   time to developing CIN+ or VaIN+ from first CIN+ diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age >= 20 years

2. Those with a previous history of CIN+

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Medical Foundation	Taoyuan City		Taiwan	333

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05931354
• Other Study ID Numbers: 201700471B0
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 5, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gung Memorial Hospital: Cervical Intraepithelial Neoplasia; hysterectomy; human papillomavirus; vaginal intraepithelial neoplasia
• Additional relevant MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia

Study Results

No Results Posted as of Jul 5, 2023