Observational management of young women under the age of 25 with cervical intraepithelial neoplasia (CIN3)

Not Applicable

• Conditions: Cervical Intraepithelial Neoplasia (CIN) 3; Cancer - Cervical (cervix)

• Registration Number: ACTRN12617000930381
• Lead Sponsor: niversity of Otago, Christchurch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-27
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified