|- candidate number||12054|
|- NTR Number||NTR3350|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-mrt-2012|
|- Secondary IDs||2010/04 WBO|
|- Public Title||Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial 3B.|
|- Scientific Title||Offering hrHPV testing on self-sampled cervicovaginal specimens to women who are non-responder in the conventional cervical screening program.|
|- hypothesis||In the PROHTECT-3B trial, we offer hrHPV testing on self-sampled (cervico-)vaginal specimens obtained by either a lavage device or a brush device. The respons rate of the two devices will be compared. Also, the user comfort and sensitivity and specificity for high grade CIN and cervical cancer (CIN2+/CIN3+) of two devices will be compared.|
The hypothesis is that the respons rate of the brush device is at least as good as the respons of the lavage device.
|- Healt Condition(s) or Problem(s) studied||Cervical intraepithelial neoplasia (CIN), Cervix cancer|
|- Inclusion criteria||1. Women invited for the cervical cancer screening program in 2008 (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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-okt-2011|
|- planned closingdate||1-apr-2013|
|- Target number of participants||34000|
|- Interventions||This randomized-controlled trial is coordinated by the Radboud University Medical Centre (RUMC) and performed in collaboration with VUmc, the screening organizations Mid-West and East and RIVM. In the regions Noord-Holland/ Flevoland/ Utrecht and Gelderland, non-attendees of the regular screening programme will be invited to participate to self-sampling. Based on earlier trials, we expect about 27 percent of these women will respond by sending a self sampled specimen for hrHPV testing, of whom 8-10 percent will be hrHPV positive (Gök, 2010). Randomization of the participants is performed to determine whether the respons rate of the brush self-sampling device is at least as good as the respons rate of the lavage self-sampling device. Follow-up of the HPV positive cases will be performed with cytology via a physician-taken smear. |
|- Primary outcome||Participation rate of women in both study arms.|
|- Secondary outcome||1. User comfort of both self-sample devices;|
2. The number of CIN 2+ and CIN 3+ lesions in both study arms;
3. hrHPV prevalence in both study arms;
4. Compliance in follow-up after a positive hrHPV result.
|- Trial web site||www.thuistestHPV.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. R.P. Bosgraaf|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.L.M. Bekkers|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen, VU University Medical Center, Department of Pathology, National Institute for Public Health and the Environment (RIVM)|
(Source(s) of Monetary or Material Support)
|Radboud University Nijmegen Medical Centre, Department of Obstetrics and Gynaecology, VU University Medical Center, Department of Pathology, National Institute of Public Health and Environmental Protection (RIVM), Screening organization East, Screening organization Mid-West|
|- Publications||Bais et al. Int. J. Cancer 2007; 120(7):1505-1510.|
Gok et al. BMJ 2010; 340:1040.
Gok et al. Int. J. Cancer 2011; Apr 2011.
|- Brief summary||In this randomized-controlled trial, 34.000 registered non-attendees in the regions Noord-Holland/ Flevoland/ Utrecht and Gelderland will be enrolled for self-sampling.|
Previous PROHTECT trials have shown that offering a user-friendly self-sampling method for collecting (cervico-) vaginal cell material at home enabled the recruitment of about one-third of these women, who are otherwise unwilling or unable to submit to cytological screening, into the screening program. Consequently, a significant number of CIN2+/CIN3+ lesions were found.
In this PROHTECT-3B trial, we extend the evaluation of offering in two study arms either a lavage self-sampling device or a brush self-sampling device to non-attendees.
For this purpose, 34,000 non-responders from the year 2008 are enrolled for self-sampling. Follow-up of hrHPV-positive self-sampling responders will be performed with cytology via a physician-taken smear.
We aim to reveal:
1. The participation rate of hrHPV positive women in the both study arms;
2. User comfort of both self-sample devices;
3. The number of CIN 2+ and CIN 3+ lesions in both study arms;
4. hrHPV prevalence in both study arms;
5. Compliance in follow-up after a positive hrHPV result.
|- Main changes (audit trail)|
|- RECORD||14-mrt-2012 - 25-mrt-2012|