PRINCess Trial

Prediction of Regression in CIN2

• Coordinating centre in Christchurch• Mainly NZ but Sydney and Melbourne just

completing their approval processes• Aim to recruit 600• Numbers now over 300• We have 6 in the trial

• Eligible women have histologically proven CIN 2• Some referrals will be with recurrent LSIL

smears• Must be able to attend for 6 monthly

colposcopy with smear, biopsy and HPV testing for 2 years

• Loss to follow-up is registered as a serious adverse event

• If the CIN 2 regresses they will be discharged back to primary care.

• If CIN 2 is still present at 2 years it is treated• CIN 3 is treated at any time in the trial

• Why is it an important trial?• Safety• Prevent over-treatment• Many countries don’t screen before 25;

England, Holland, Australia• Primary HPV screening will mean screening

from an older age

• It is hoped we will also get information on HPV types for prevalence data and perhaps for disease severity prediction.

• Information on lesion size for disease prediction

• Perhaps some biomarkers for disease prediction

• Those are all secondary to the primary aim which is to determine the safety of conservative management of CIN 2 in women under 25 years