title: Observational Management of CIN 2 in Young Women: A Prospective Multicenter Trial.
abstract: OBJECTIVE
  We present the rationale and methods for PRINCess-a multicenter prospective trial-which aims to determine outcome and predictors of regression in a large cohort of women younger than 25 years with cervical intraepithelial neoplasia grade 2 (CIN 2) undergoing observational management.
  
  
  METHODS
  Six hundred women younger than 25 years with newly diagnosed biopsy-proven CIN 2 are being recruited to observational management (i.e., repeat colposcopy, cytology, and cervical biopsy every 6 months for 2 years). Five hundred fifty-two women from throughout New Zealand and 1 site in Australia have been recruited so far. Measures include histology, cytology, human papillomavirus genotyping, and immunohistochemical staining. Women who develop CIN 3 will be treated with large loop excision of the transformation zone. The primary outcomes are rates of clinical regression of CIN 2 (i.e., 2 consecutive colposcopy follow-ups showing CIN 1 or normal), loss to follow-up, and progression to invasion.
  
  
  CONCLUSIONS
  The optimal treatment for young women with a diagnosis of CIN 2 is controversial. Although many undergo surgical treatment, observational management is increasingly recommended. However, there is little evidence from large clinical trials of the safety and practicality of observational management of young women with CIN 2. When completed, we will have adequate evidence by which to counsel women regarding their likely outcomes and to offer advice on clinical follow-up protocols.
authors.affiliation: 1Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand; 2Christchurch Women's Hospital, Christchurch, New Zealand; 3Department of Pathology, University of Otago, Christchurch, New Zealand; 4Canterbury Health Laboratories, Christchurch Hospital, Christchurch, New Zealand; 5Women's Health Research Centre, Department of General Practice and Primary Healthcare, University of Otago, Wellington, New Zealand; 6Department of Microbiology, University of Otago, Dunedin, New Zealand; 7Southern Community Laboratories, Dunedin, New Zealand; 8Waikato Hospital, Hamilton, New Zealand; 9Dunedin Hospital, Dunedin, New Zealand; 10Southland Hospital, Invercargill, New Zealand; 11Wellington Hospital, Wellington, New Zealand; and 12National Women's Health, Auckland District Health Board, Auckland, New Zealand.
authors.forename: Peter
authors.initials: P
authors.lastname: Sykes
authors.forename: Carrie
authors.initials: C
authors.lastname: Innes
authors.forename: Dianne
authors.initials: D
authors.lastname: Harker
authors.forename: Martin
authors.initials: M
authors.lastname: Whitehead
authors.forename: Rachael
authors.initials: R
authors.lastname: van der Griend
authors.forename: Beverley
authors.initials: B
authors.lastname: Lawton
authors.forename: Merilyn
authors.initials: M
authors.lastname: Hibma
authors.forename: Peter
authors.initials: P
authors.lastname: Fitzgerald
authors.forename: Narena
authors.initials: N
authors.lastname: Dudley
authors.forename: Simone
authors.initials: S
authors.lastname: Petrich
authors.forename: Jim
authors.initials: J
authors.lastname: Faherty
authors.forename: Cecile
authors.initials: C
authors.lastname: Bergzoll
authors.forename: Lois
authors.initials: L
authors.lastname: Eva
authors.forename: Catherine
authors.initials: C
authors.lastname: Parker
authors.forename: Lynn
authors.initials: L
authors.lastname: Sadler
authors.forename: Bryony
authors.initials: B
authors.lastname: Simcock
mesh_terms: D000293:Adolescent; D001315:Australia; D001706:Biopsy; D002278:Carcinoma in Situ / Q000628:therapy*; D003127:Colposcopy; D003584:Cytological Techniques; D019468:Disease Management; D005260:Female; D060005:Genotyping Techniques; D006651:Histocytochemistry; D006801:Humans; D007150:Immunohistochemistry; D009520:New Zealand; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000628:therapy*; D055815:Young Adult