Skip to content

IMPROVE-study

Prospective randomized pilot implementation trial of HPV self-sampling in primary cervical screening

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28209
Enrollment
12000
Registered
2015-03-13
Start date
2015-03-16
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), Cervical cancer

Interventions

Women who are eligible for the national cervical screening program receive an invitation to participate in this study. When women return a signed informed consent form, they will be randomized between
women in the control arm will be asked to perform additional self-sampling for hrHPV DNA testing. This cross-testing is performed to see if individual HPV results match between the self-sample and the

Sponsors

VU University Medical Center, Department of Pathology Erasmus Medical Center, Department of Pathology Radboud University Medical Center, Department of Gynaecology National Institute for Public Health and the Environment (RIVM)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women invited for the national screening program in 2015 (ages 30-60 years) 2. Women should reside in the regions covered by district health authorities of Noord-Holland, Flevoland, Utrecht, Zuid-Holland, Zeeland, Gelderland en Overijssel (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. Cervical smear in the past 12 months or under follow-up/treatment by gynaecologist 3. Current pregnancy 4. Hysterectomy, incl. cervix

Design outcomes

Primary

MeasureTime frame
The number of CIN2+ and CIN3+ lesions in both study arms

Secondary

MeasureTime frame
Comparison of the cost-effectiveness between both study arms

Contacts

Public ContactN.J. Polman

VU medisch centrum; Department of Pathology

n.polman@vumc.nl+31 20 444 01 02

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)