ISRCTN91252554已完成未知
Randomized trial of immediate treatment versus colposcopic followup for biopsy-proven cervical intraepithelial neoplasia (CIN) 1
McMaster University (Canada) - Faculty of Health Sciences0 个研究点目标入组 415 人开始时间: 2005年9月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 415
研究概览
简要总结
2011 results in https://pubmed.ncbi.nlm.nih.gov/21425144/ (added 12/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Documented CIN 1 by histologic assessment as the highest grade lesion present
- •2. Lesion confined to the cervix and completely visualized
- •3. Be 16 years or older, female
排除标准
- •Among patients satisfying the inclusion criteria the following will be excluding characteristics:
- •1. Index Pap smear showing CIN 2, 3 or cancer:
- •1.1. Index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia or malignancy requiring immediate investigation
- •1.2. Patients with previously identified CIN 1 by biopsy who are already in a surveillance program
- •2. Unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1
- •3. Pregnancy
- •4. Prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy
- •5. Prior gynecologic cancer
- •6. Prior pelvic radiation therapy
- •7. Inability to attend outpatient followup visits because of geographic inaccessibility
- •8. Other malignancies except non-melanoma skin cancer
- •9. Immunosuppression due to diseases such as Acquired Immune Deficiency Syndrome (AIDS), organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus
- •10. Cognitively impaired or otherwise unable to obtain written informed consent
- •11. Extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia
- •12. Colposcopically visible condyloma outside of the transformation zone
- •13. Known allergy to local analgesics
- •14. Clinically evident vaginitis must be treated and resolved prior to entry on the trial
- •15. Inability to read and respond in English
- •16. Failure to provide informed consent
研究者
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