NL-OMON54267招募中3 期
Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy - DEPART-trial
GenesisCare Cancer Care Research Pty Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Prevention cohort
- •Evidence of nodules and/or cords in the affected hand consistent with DD
- •History of progressive DD over previous 6 months
- •No previous radiotherapy to the affected hand
- •No history of radiation sensitivity diseases (eg Scleroderma, Ataxia
- •Telangiectasia, Li Fraumeni)
- •No previous SF, NA or CI in the affected hand
- •Absence of flexion contractures: Passive extension deficit (PED) must be less
- •than, or equal to, 10 degrees (<=10°) in any joints of the affected hand.
- •Patient Consent
- •Adjuvant cohort
- •Local treatment with Needle Aponeurotomy (NA) of flexion contracture(s)
- •performed within 6-12 weeks prior to post-intervention baseline measurements
- •No previous radiotherapy to the affected hand
- •No history of radiation sensitivity diseases (eg Scleroderma, Ataxia
- •Telangiectasia, Li Fraumeni)
- •Lack of major acute complications due to surgical intervention and <=20
- •degrees PED in each joint of treated ray
- •Able to commence radiotherapy treatment within 12 weeks of local treatment
- •with Needle Aponeurotomy (NA).
- •Patient consent
排除标准
- •Prevention cohort
- •No evidence of nodules and/or cords in the affected hand consistent with DD
- •No history of progressive DD over previous 6 months
- •Previous radiotherapy to the affected hand
- •History of radiation sensitivity diseases (eg Scleroderma, Ataxia
- •Telangiectasia, Li Fraumeni)
- •Previous SF, NA or CI in the affected hand
- •Prescence of flexion contractures: Passive flexion contracture greater than
- •10 degrees (>10°) in all joints of the affected hand.
- •Age <= 30
- •No patient Consent
- •Adjuvant cohorts
- •Local treatment with Needle Aponeurotomy (NA) of flexion contracture(s) is
- •not performed within 6-12 weeks prior to post-intervention baseline measurements
- •Age<=30
- •Previous radiotherapy to the affected hand
- •History of radiation sensitivity diseases (eg Scleroderma, Ataxia
- •Telangiectasia, Li Fraumeni)
- •Major acute complications due to surgical intervention and >20 degrees PED in
- •each joint of treated ray
- •Not able to commence radiotherapy treatment within 12 weeks of local
- •treatment with Needle Aponeurotomy (NA).
- •No patient consent
研究者
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