跳至主要内容
临床试验/ACTRN12622000886785
ACTRN12622000886785招募中未知

Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer

niversity of Queensland0 个研究点目标入组 100 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方
入组人数
100

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
Diagnosis
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

  • Females, over 18 years, with histologically confirmed squamous cell carcinoma (SCC), adenocarcinoma or melanoma of the vulva
  • - Undergo inguino-femoral lymphadenectomy /sentinel node biopsy according to local clinical practice management guidelines
  • - Signed written informed consent
  • - Negative serum pregnancy test less than or equal to 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause.

排除标准

  • - Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget’s disease)
  • - SCC of the vulva with depth of invasion less than or equal to 1 mm
  • - Clinical or medical imaging evidence of regional and/or distant metastatic disease
  • - Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
  • - Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ.

研究者

发起方
niversity of Queensland

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