NCT05265429招募中不适用
Biology of Young Lung Cancer Study: The YOUNG LUNG Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Repository of specimens and data
研究概览
简要总结
The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.
详细描述
This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:
- Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease
- Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger
- Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients
- Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger
Study procedures will include:
- Collecting information from participants' medical record and two (2) short questionnaires
- Collecting blood and/or saliva samples
- Collecting tumor tissue samples (optional)
It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45 and under at lung cancer diagnosis
- •Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
- •Provision of written informed consent
- •Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
- •Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent
排除标准
- •Individuals who decline to sign consent
- •Individuals who are unable to give consent or assent and are without a designated healthcare proxy
- •Compromise of patient diagnosis or staging if tissue is used for research
结局指标
主要结局
Repository of specimens and data
时间窗: 5 years or study closure
Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.
次要结局
- Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes(5 years or study closure)
- Number of patients with targetable somatic alterations in known oncogenic driver genes(5 years or study closure)
- Number of patients with predicted oncogenic alterations in unknown driver genes(5 years or study closure)
研究者
Pasi Janne, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (4)
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