ACTRN12616000645459终止未知
Prospective collection of clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand
niversity Of Otago Christchurch0 个研究点目标入组 316 人开始时间: 2016年5月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 316
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •.1.Able to give informed consent.
- •2.Early vulval carcinoma confirmed histologically (unifocal, invasive squamous cell carcinoma less than 4cm in greatest dimension - not including insitu component)
- •3.Depth of invasion greater than 1mm
排除标准
- •1.Tumour involves urethra, anus or middle 1/3 of vagina.
- •2.Reconstruction of the vulva using a flap has been performed with removal of the
- •primary lesion .
- •3.Clinical evidence of groin node metastasis.(palpation, imaging , FNA)
- •4.Prior history of SCC of the genital tract, anus, or lower body.
- •5.Prior groin node dissection
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