NL-OMON51652招募中不适用
Predicting Response In Cervical intraepithelial neoplasia to Topical Imiquimod treatment (PRedICT-TOPIC) - PRedICT-TOPIC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Primary cHSIL lesions (e.g. CIN3 or CIN 2), histologically confirmed by
- •diagnostic biopsy
- •NB: In case of CIN 2, <30 years, expectative management must be discussed
- •according to the Dutch national guideline with the patient, if the patient
- •prefers imiquimod therapy the patient can be treated with imiquimod and
- •enrolled in the study, if the patient prefers expectative management they can
- •be enrolled in the observational CIN 2 arm.
- •- Recurrent or residual cHSIL lesions after initial LLETZ treatment (e.g. CIN2
- •or CIN3), histologically confirmed by diagnostic biopsy
- •- Age of 18 years or older
排除标准
- •- Concomitant diagnoses of VAIN (vaginal intraepithelial neoplasia e.g. vaginal
- •- PAP 4 cytology as indication for the baseline colposcopy at study entrance
- •- Adenocarcinoma in situ (AIS) diagnosis
- •- Previous imiquimod therapy for cHSIL
- •- previous cervical malignancy
- •- current malignant disease
- •- immunodeficiency (including HIV/AIDS and immunosuppressive medication)
- •- pregnancy
- •- legal incapability
- •- insufficient knowledge of the Dutch language
研究者
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