Efficacy of addition of hrHPV testing by Hybrid Capture II to conventional cytological screening for cervical cancer: 5 years follow-up.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21745

Enrollment

50000

Registered

2009-06-10

Start date

2003-10-01

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

Cervical intraepithelial neoplasia (CIN), Cervix cancer

Interventions

In the VUSA-SCREEN, women participating the regular cervical screening program were offered high-risk human papillomavirus (hrHPV) test, using the commercially available and FDA approved Hybrid Captur

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women invited for the cervical cancer screening program (ages 30-60 years); 2. General practitioner affiliated with SALTRO laboratory.

Exclusion criteria

Exclusion criteria: 1. Not called for screening, i.e., ages under 30 years, or over 60 years; 2. Follow-up of previous non-normal cytology within the current screening round of the program, i.e., abnormal cytology or lesion ¡ÝCIN3 less than 2 years before inclusion; 3. Current pregnancy; 4. Status after extirpation of the uterus or amputation of the portio.

Design outcomes

Secondary

Measure	Time frame
As a secondary outcome measure, histologically confirmed cervical intra-epithelial neoplasia grade 2 will also be investigated, since current guidelines recommend ablative treatment for these lesions as well. Other secondary parameters obtained include progression and regression of cytology diagnoses, clearance and acquisition of hrHPV infections and the number of referrals for colposcopically-directed biopsies.	—

Measure

Time frame

As a secondary outcome measure, histologically confirmed cervical intra-epithelial neoplasia grade 2 will also be investigated, since current guidelines recommend ablative treatment for these lesions as well. Other secondary parameters obtained include progression and regression of cytology diagnoses, clearance and acquisition of hrHPV infections and the number of referrals for colposcopically-directed biopsies.

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Primary

Measure	Time frame
The primary outcome measure of VUSA-SCREEN is the occurrence of histologically confirmed cervical intra-epithelial neoplasia grade 3 (CIN3) lesions or (micro-) invasive carcinoma of the cervix found during the follow-up of currently diagnosed abnormalties, i.e., within 5 years. For women whose cytology results either regress to normal (in the unblinded trial of women with mild cytological abnormalities) or who clear an infection with hrHPV without cytological abnormalities (in the blinded trial of women with normal cytology diagnoses), we assume that no precursor lesions of cervical cancer are present. They will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint. This policy complies with regular cervical screening in The Netherlands.	—

Measure

Time frame

The primary outcome measure of VUSA-SCREEN is the occurrence of histologically confirmed cervical intra-epithelial neoplasia grade 3 (CIN3) lesions or (micro-) invasive carcinoma of the cervix found during the follow-up of currently diagnosed abnormalties, i.e., within 5 years. For women whose cytology results either regress to normal (in the unblinded trial of women with mild cytological abnormalities) or who clear an infection with hrHPV without cytological abnormalities (in the blinded trial of women with normal cytology diagnoses), we assume that no precursor lesions of cervical cancer are present. They will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint. This policy complies with regular cervical screening in The Netherlands.

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Contacts

Public ContactD.C. Rijkaart

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)