Lung Cancer Screening of Family Members of Patients With Mutation-Driven Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,753
- 试验地点
- 1
- 主要终点
- Number of lung cancers found
研究概览
简要总结
This is a single-armed screening research study which screens immediate family member of lung cancer patients with a driver mutation to see if lung cancer can be inherited and whether researchers can find lung cancer early. Immediate family members of lung cancer patients will be 40-80 years old and screened using a low dose CT scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Current diagnosis of lung cancer with a driver mutation.
- •Known driver mutation (e.g. via NGS, PCR, IHC, FISH, RT-PCR etc.)
- •Able and willing to give informed consent.
- •Able and willing to complete the screening questionnaire.
排除标准
- •There are no exclusion criteria for Cohort A.
- •Inclusion Criteria:
- •Must have a first degree relative (mother, father, sibling, biological child) eligible for Cohort A. Note: Multiple first degree relatives of a Cohort A eligible participant may be approached for participation into the trial.
- •Smoked < 20 pack years; a. Pack years = numbers of packs per day × number of years smoked; b. One pack year is the equivalent of smoking an average of 20 cigarettes (1 pack) per day for a year.
- •Be able to undergo a low dose chest CT scan.
- •If an upper respiratory infection (pneumonia, COVID19, flu, etc.) occurred in the last 3 months, this infection must have resolved by time of enrollment.
- •Able and willing to provide informed consent.
- •Able and willing to comply with the protocol requirements
- •Exclusion Criteria:
- •Previous history of lung cancers.
- •Symptoms suggestive of presence of current lung cancer, including (but not limited to): unexplained weight loss of over 15 pounds within the last 12 months or unexplained hemoptysis.
- •Pregnant at time of enrollment.
- •History of any type of cancer within 5 years, with the exception of in situ carcinomas and non-melanoma skin cancers (if excised).
- •Current smoker.
- •Smoked ≥ 20 pack years.
- •Had a chest CT scan within 1 year of study entry.
研究组 & 干预措施
Low Dose CT Scan of First Degree Relatives of Lung Cancer Patients
First degree relatives of patients with lung cancer with a known driver mutation will receive a low dose CT scan of the chest to screen for lung abnormality.
干预措施: Low Dose CT Scan (Diagnostic Test)
结局指标
主要结局
Number of lung cancers found
时间窗: 2 years
Determine the number of lung cancers found in low dose CT scans of first degree relatives of lung cancer patients with known driver mutations.
次要结局
- Number of follow-up CT scans(2 years)
- Number of lung abnormalities detected(2 years)
- Number and type of biopsies performed(2 years)
- Number and type of resections performed(2 years)
- Number of Adverse Events related to study procedures and follow-up interventions(2 years)
- Stage of Lung Cancers Found(2 years)
研究者
Hari Keshava
HS Assistant Clinical Professor
University of California, Irvine