HPV test and post-treatment and long term follow up

A retrospective longitudinal clinical cohort study to evaluate HPV testing post-treatment and the long term risk at (cervical) disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29304

Enrollment

440

Registered

2008-10-01

Start date

2008-12-01

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

Cervical Intraepithelial neoplasia (CIN), Human Papillomavirus (HPV), post-treatment, long term, recurrence, recidive In Dutch: (pre)maligne afwijkingen cervix, CIN, Humaan papillomavirus (HPV), post-treatment, lange termijn, recidief

Interventions

1. Cervical/vaginal sample for cytology as well as hrHPV testing. 2. Gynaecological history and questionnaire to identify risk factors. 3. Colposcopy examination at indication.

Eligibility

Inclusion criteria

Inclusion criteria: All subjects must satisfy the following criteria at study entry: 1. Previous participation in one of the following studies: “Addition of high-risk HPV testing improves the current guidelines on follow-up after treatment for Cervical Intraepithelial Neoplasia”, conducted by Nobbenhuis et al., “Condom use promotes regression of cervical intraepithelial neoplasia and clearance of human papillomavirus: a randomized clinical trial” conducted by Hogewoning et al., or “Post treatment CIN: Randomized Clinical Trial using hrHPV testing for prediction of residual/ recurrent disease ”, conducted by Bais et al. 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

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary study outcomes include: - The results of cervical cytology. - The presence of hrHPV. - Type of hrHPV. - The results of the questionnaire (including sexual behavior, smoking and previous vaccination). - The results of revision and hrHPV testing of all positively identified subjects who have received a cervical treatment (including hysterectomy) in the period between the last visit of the previous study and the current study. - Histology results of all endocervix samples and biopsies taken.	—

Measure

Time frame

Secondary study outcomes include: - The results of cervical cytology. - The presence of hrHPV. - Type of hrHPV. - The results of the questionnaire (including sexual behavior, smoking and previous vaccination). - The results of revision and hrHPV testing of all positively identified subjects who have received a cervical treatment (including hysterectomy) in the period between the last visit of the previous study and the current study. - 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)