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临床试验/EUCTR2016-003036-20-IT
EUCTR2016-003036-20-IT进行中(未招募)1 期

A randomized trial of multifactorial primary prevention in high risk subjects candidate to a lung cancer early detection CT program - SMILE

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI0 个研究点目标入组 2,000 人开始时间: 2021年6月8日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
2,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age between 55 and 75 years
  • Heavy smoker (=30 packages/year)
  • Eligibility to screening with annual chest CT
  • Availability and ability to use the Internet via PC, tablet or smartphone
  • Ability to understand the project to which you intend to participate
  • No tumors in the last 5 years
  • Signature of informed consent for enrollment in the study and for the processing of personal data
  • 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 1350
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 650

排除标准

  • Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch; coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate)
  • Chronic treatment with cardioASA, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)
  • Treatment with methotrexate
  • Existing Mastocytosis
  • History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs
  • Gastroduodenal ulcer
  • Hemorrhagic diathesis
  • Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)
  • Severe kidney failure
  • Serious psychiatric problems
  • Previous treatment with Cytisine
  • Abuse of alcohol or other substances (even before)

研究者

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