NCT05931354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

7 years

First QC Date

June 27, 2023

Last Update Submit

June 27, 2023

Conditions

Cervical Intraepithelial NeoplasiaHysterectomyHuman PapillomavirusVaginal Intraepithelial Neoplasia

Keywords

Cervical Intraepithelial Neoplasiahysterectomyhuman papillomavirusvaginal intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

  • progression rate of CIN+ or VaIN+

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

    5 years

Study Arms (1)

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

Interventions

HPV test and Pap SmearOTHER

HPV test and Pap Smear

CIN_Group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age \>= 20 years
  • Those with a previous history of CIN+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Medical Foundation

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Lan-Yan Yang, PhD

CONTACT

88633281200lyyang0111@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 5, 2023

Study Start

July 1, 2017

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 5, 2023

Record last verified: 2023-06

Locations

TW(1)