A prospective multicentre trial of observational management of CIN3 in women under the age of 25: safety and rate of spontaneous regression

niversity of Otago, Christchurch0 个研究点目标入组 9 人开始时间: 2017年6月27日最近更新: 2019年11月4日

试验速览

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•Age under 25 at date of initial biopsy.
•- Attending colposcopy clinic as a result of an abnormal smear but without a history of prior high grade abnormality.
•- Biopsy proven CIN3 (or CIN2/3).
•- Entire lesion accessible to colposcopy.
•- Participants in trial agree to six monthly colposcopy and cervical smear and biopsy for a total of two years.
•- Cytology and pathology reviewed and CIN3 confirmed at a multidisciplinary meeting and no other clinical factor was identified that would exclude them from the trial.
•- Signed informed consent

•- High grade cytological or histological abnormality prior to this referral.
•- Unsatisfactory colposcopy.
•- Large complex colposcopic abnormality where adequate histological sampling difficult.
•- Cytology suspicious of invasion or glandular abnormality.
•- Patients unwilling or unable to attend follow up.
•- Patients whose cytology and histology have not been reviewed at MDM.
•- Clinical suspicion of invasion or AIS.
•- Any glandular histological or cytological abnormality.
•- Concern on behalf of treating doctor that patient is unlikely to attend follow up.
•- Immunosuppression.
•- Pregnancy
•- Post-coital bleeding or any other irregular vaginal bleeding not attributable to oral contraceptive related break through bleeding

发起方

niversity of Otago, Christchurch