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Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial 3.

Improving detection-efficiency of CIN2+/CIN3+ among non-responder women who test positive for hrHPV on a self-collected sample.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29624
Enrollment
45000
Registered
2010-11-17
Start date
2010-10-01
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

This randomized-controlled trial is coordinated by the VU University medical center (VUmc) and performed in collaboration with UMCN, the screening organizations Midden-West and Oost and RIVM. In the r

Sponsors

VU University Medical Center, Department of Pathology, Univerisity Medical Center Nijmegen, Comprehensive Cancer Center (IKA) Amsterdam , National Institute for Public Health and the Environment (RIVM),
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women invited for the cervical cancer screening program in 2007 (ages 30-60 years), who did not respond to an initial invitation and a recall after 3-6 months; 2. Women should reside in the regions covered by district health authorities of Noord-Holland, Flevoland, Utrecht and Gelderland (in the Netherlands).

Exclusion criteria

Exclusion criteria: 1. Not in the population based screening program, i.e. ages under 30 years, or over 60 years; 2. Actively responded to the invitation or recall of the cervical screening program by undergoing a cervical smear at the general practitioner; 3. Under follow-up by gynaecologist for previous abnormal cytology, and/or CIN3 lesion or worse less than 2 years before inclusion; 4. Current pregnancy; 5. Status after hysterectomy or amputation of the portio.

Design outcomes

Primary

MeasureTime frame
The number of CIN 2+ and CIN 3+ lesions in both triage strategies.

Secondary

MeasureTime frame
1. Participation rate of hrHPV positive women in both triage strategies; 2. Comparison of the cost-effectiveness between both triage strategies.

Contacts

Public ContactV.M.J. Verhoef
violaverhoef@hotmail.com+31 (0)20 4440102

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)