HPV testing and the long term risk at cervical disease

HPV testing and the long term risk at cervical disease - HPV test and long term follow-up

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32541

Enrollment

353

Registered

2008-10-31

Start date

2009-01-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(pre) malignant cervical disease Cervical Intraepithelial Neoplasia) CIN

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Pregnancy

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results