Condition category
Cancer
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hpvthuistest.nl

Contact information

Type

Scientific

Primary contact

Dr D A M Heideman

ORCID ID

Contact details

VU University Medical Center
Department of Pathology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
dam.heideman@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2006/01WBO

Study information

Scientific title

Acronym

PROHTECT

Study hypothesis

The main aims of the PROHTECT trial are to find out whether the compliance rate of the cervical screening programme can be improved by offering a self-sampling method for collecting cervicovaginal cell material at home for Human PapillomaVirus (HPV) testing, and consequently the (cost)-effectiveness of screening will be enhanced due to increased detection of high grade Cervical Intraepithelial Neoplasia (CIN) lesions or worse (more than or equal to CIN grade two to three)?

Ethics approval

The PROHTECT trial has been approved by the Dutch Ministry of Health, Welfare and Sports (reference number: 2006/01WBO), date of approval: 11th May 2006. In addition, the Ethics Board of the VU University Medical Center has approved the study.

Study design

Randomised, controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Cervical Intraepithelial Neoplasia (CIN), cervix cancer, uterus

Intervention

In the PROHTECT trial, the effect of the addition of offering self-sampling at home to women who are not responding to the invitation of the regular cervical screening program as well as a first recall, onto the participation rate is evaluated in a randomised controlled trial design.

During the trial, participants will receive either a second recall for the regular screening (control group), or receive a kit for self-sampling of a cervicovaginal specimen at home and subsequent referral recommendations based on the presence or absence of high-risk Human PapillomaVirus (hrHPV) in the self-taken specimen (intervention group, hrHPV test results disclosed).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the change in compliance rate, i.e., the increase in attendance rate of the cervical screening program after a second recall by using self-sampling material for hrHPV testing, compared to a control group that will receive a second recall for cytological testing (similar to the conventional first recall).

Secondary outcome measures

The secondary outcome measures include:
1. The women characteristics, i.e., the prevalence of HPV and the number of detected high-grade CIN lesions for compliance of referral and treatment among non-responder women compared to women participating in the conventional screening program.
2. Evaluation of the cost-effectiveness of self-sampling when offered in the nation-wide screening program, i.e., counter valuation of the effects on costs versus improved detection rate of premalignant lesions.

Overall trial start date

01/10/2006

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women invited for the cervical cancer screening program (ages 30 to 60 years), but who are not responding to their invitation as well as their recall (three months after)
2. Residing in the region covered by district health authorities of North Holland and Flevoland (in the Netherlands)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

45000

Participant exclusion criteria

1. Not called for screening, i.e., ages under 30 years, or over 60 years
2. Actively responded to the invitation or first recall of the cervical screening program by undergoing a cervical smear at the general practitioner
3. Living outside the region covered by district health authorities of North Holland and Flevoland
4. Under follow-up by gynaecologist for previous non-normal cytology, i.e., abnormal cytology and/or CIN three lesion or worse less than two years before inclusion
5. Current pregnancy
6. Status after extirpation of the uterus or amputation of the portio

Recruitment start date

01/10/2006

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (The Netherlands)

Sponsor details

Department of Pathology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
cjlm.meijer@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Comprehensive Cancer Centre (Integraal Kankercentrum) (The Netherlands) 2. VU University Medical Center (The Netherlands) 3. National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Brink et al. J Clin Microbiol. 2006; 44:2518-23.
Bais et al. Int. J. Cancer submitted

Publication citations

Additional files

Editorial Notes