a retrospective longitudinal clinical cohort study to investigate HPV testing post-treatment and the risk of recurrence of (cervical) disease on the long term.

a retrospective longitudinal clinical cohort study to investigate HPV testing post-treatment and the risk of recurrence of (cervical) disease on the long term. - HPV test post-treatment and follow-up

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32424

Enrollment

445

Registered

2009-03-18

Start date

2009-08-04

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

cervical cancer CIN

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All subjects must satisfy the following criteria at study entry: - Previous participation in one of the studies, described in section study population - Written informed consent prior to enrolment. - Sufficient knowledge of the Dutch or English language. - The intention to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: Pregnancy (or delivered within three months)

Design outcomes

Primary

Measure	Time frame
The main study parameter is the number of histological confirmed cases of high-grade disease (including CIN 2/3, AIS and VaIN 2/3), diagnosed after a follow-up period of up to 18 years after treatment for a high-grade cervical lesion (CIN 2/3).	—

Secondary

Measure	Time frame
The secondary study parameters include: - the results of cervical cytology - the presence of hrHPV - the type of hrHPV - the results of the questionnaire (including sexual behavior, smoking and previous vaccination) - the histological results of all endocervical samples and biopsies taken in the study and revision and additional hrHPV testing of all "interval" lesions in between the index study and the current study.	—

Measure

Time frame

The secondary study parameters include: - the results of cervical cytology - the presence of hrHPV - the type of hrHPV - the results of the questionnaire (including sexual behavior, smoking and previous vaccination) - the histological results of all endocervical samples and biopsies taken in the study and revision and additional hrHPV testing of all "interval" lesions in between the index study and the current study.

—

Countries

Netherlands

Outcome results