跳至主要内容
临床试验/NCT03802981
NCT03802981进行中(未招募)不适用

Thoracic Surgery Oncology Group (TSOG) Protocol: Registry Trial of Active Surveillance for Multifocal Ground Glass Opacities (GGOs)

Memorial Sloan Kettering Cancer Center60 个研究点 分布在 2 个国家目标入组 338 人开始时间: 2019年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
338
试验地点
60
主要终点
lung cancer-specific survival

研究概览

简要总结

The purpose of this registry study is to actively monitor people with GGOs and collect information about them, so that investigators can learn more about these lesions and about the risk of developing lung cancer in study participants whose GGOs are being monitored in the active surveillance program.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years
  • Have two or more GGOs on initial CT imaging
  • GGOs must be measure ≤3.0 cm and ≥0.6 cm in the greatest dimension
  • GGOs must be greater than half ground glass
  • A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible, at the discretion of the clinician and/or investigator, if they meet the above criteria.

排除标准

  • Patients who are actively undergoing lung cancer treatment or have a history of lung cancer, except for cases of completely resected pathologic stage IA nonsmall cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection of the NSCLC and confirmation of stage on final pathologic assessment.
  • The presence of any solid lesion ≥0.6 cm suspicious for malignancy.
  • Patients who are actively undergoing treatment for other malignancies

结局指标

主要结局

lung cancer-specific survival

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (60)

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