HPV testing and the long term risk at cervical disease

Phase 4

Recruiting

• Conditions: (pre) malignant cervical disease; Cervical Intraepithelial Neoplasia); CIN; 10038597; 10013364

• Registration Number: NL-OMON32541
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 353

Inclusion Criteria

Previous participation in study mentioned in study by M. Nobbenhuis; Relation of human papillomavirus status to cervical lesions and the consequences for cervical cancer screening; a prospective study
Written informed consent
Sufficient knowledge of Dutch/ English language
Intention to comply with protocol requirements

Exclusion Criteria

Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the cumulative number of histological confirmed<br /><br>cases of Cervical Intraepithelial Neoplasia (CIN) 2 or 3 or adenocarcinoma in<br /><br>situ (AIS), diagnosed after a follow up period of up to 18 years after an<br /><br>abnormal cervical smear. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters include:<br /><br>- the results of cervical cytology<br /><br>- the presence of hrHPV<br /><br>- type of hrHPV<br /><br>- serum E6/E7 antibody level<br /><br>- the results of the questionnaire (including sexual behavior, smoking and<br /><br>previous vaccination)<br /><br>- histology results of all endocervix samples and biopsies taken</p><br>