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HPV testing and the long term risk at cervical disease

A prospective longitudinal clinical cohort study to evaluate HPV testing and the long term risk at cervical disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24787
Enrollment
353
Registered
2008-09-30
Start date
2008-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

(pre)malignant cervical laesions, Cervical Intraepithelial neoplasia (CIN), Human Papillomavirus (HPV), long term In Dutch: (pre)maligne afwijkingen cervix, CIN, Humaan papillomavirus (HPV), lange termijn

Interventions

All women are invited to the outpatient clinic, where a blood sample and a cervical smear for cytology and HPV testing will be taken. If the HPV test is HPV positive or if cytology is abnormal a seco

Sponsors

HUMAVAC (VU University Medical Center)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All subjects must satisfy the following criteria at study entry: 1. Previous participation in the following study: 'Relation of human papillomavirus status to cervical lesions and consequences for cervical screening: A prospective study'. 2. Written informed consent prior to enrolment. 3. Sufficient knowledge of the Dutch or English language. 4. The intention to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Intraepithelial Neoplasia (CIN) 2 or 3 and adenocarcinoma in situ (AIS), diagnosed after a follow up period of up to 18 years after an abnormal cervical smear.

Secondary

MeasureTime frame
Secondary study outcomes 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

Contacts

Public ContactM. Kocken

VU university Medical Center room 6Z162 P.O. Box 7057

m.kocken@vumc.nl+31 (0)20 4444 833

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)