PRINCess: The Prediction of Regression in CIN2 - The Conservative Management of Cervical Intraepithelial Neoplasia (CIN) 2 in Young Women

PRINCess: The Prediction of Regression in CIN2 - A prospective study of young women under the age of 25 with biopsy proven CIN2 undergoing conservative management with assessment of regression, stable disease and progression.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000547943

Acronym

PRINCess

Enrollment

616

Registered

2011-05-30

Start date

2010-04-14

Completion date

2016-10-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cervical intraepithelial neoplasia 1, 2 or 3 is the term used to describe a range of cellular changes on the cervix that over time can regress to normal or progress to cervical cancer. Cervical cancers are usually preceded by a long phase of preinvasive disease. Evidence has shown that there is a 43% likelihood of regression of CIN 2, a 35% likelihood of persistence of CIN 2 and a 20% probability of progression to CIN 3. Evidence in adolescents has shown an even higher rate of regression. The current treatment for this abnormality is a LLETZ biopsy of the cervix. This treatment is associated with complications in future pregnancies – premature rupture of membranes and preterm labour. Because of the high regression rate and pregnancy complications, young women, up to age 25, with biopsy proven CIN 2 at Christchurch and Dunedin Hospitals will be offered inclusion in the study. This will involve 6 monthly colposcopy clinic visits where a cervical smear, biopsy and tests for HPV, Proex, P16, Ki67 as opposed to immediate surgical management. If there is progression of this change to CIN 3 throughout follow-up a LLETZ will be offered. Follow-up is for 24 months – if the CIN 2 abnormality persists, LLETZ will be offered.

Interventions

Conservative Management for Cervical Intraepithelial Neoplasia (CIN) 2 for 24 months i.e. six monthly colposcopy and cervical biopsy for a total of two years

Eligibility

Sex/Gender

All

Age

15 Years to 25 Years

Healthy volunteers

Inclusion criteria

All women up to the age of 25 attending colposcopy clinics with biopsy proven CIN 2 with the entire lesion accessible at colposcopy. Participants in this study must agree to six monthly colposcopy and cervical biopsy for a total of two years.

Exclusion criteria

Exclusion criteria include those women with higher grade cervical intraepithelial neoplasia and findings suspicions for invasion on colposcopic assessment. Adenocarcinoma-in-situ is an exclusion category as is incomplete colposcopy.

Outcome results