EUCTR2023-000128-12-IT招募中1 期
Single-center phase II study on the use of electrochemotherapy in the treatment of Paget's disease and high-grade or initially invasive precancerous squamous lesions of the vulva (GinOnc-ECT study) - GinOnc-ECT
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 18 人开始时间: 2023年2月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Histological diagnosis of de novo or recurrent squamous disease of vulvar VIN 2-3, microinvasive carcinoma in situ of the vulva, and noninvasive vulvar Paget's disease
- •Positivity for cervical and/or vaginal HR HPV
- •Age > 18 years
- •Karnofsky performance status >70%
- •Informed consent to participate in the study
- •Absence of indication for surgical treatment due to extension of the disease, due to patient refusal, for anaesthesiological or reconstructive reasons.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Patients with histological diagnosis of adenocarcinoma
- •Patients with concomitant and/or previous tumours
- •Pregnancy in progress
- •Chronic renal failure
- •Patients with cardiac pacemakers
- •Pulmonary pathologies with medium/severe respiratory insufficiency
- •Coagulation disorders (platelets < 70,000/mm3 and INR>1.5)
- •HPV vaccination in progress
- •Patients with immunosuppressive diseases or treatments (HIV positive)
研究者
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