Lung Cancer Risk Assessment &Amp; Etiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Frequency of germline alterations
研究概览
简要总结
This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess the frequency of germline cancer susceptibility mutations in affected and unaffected individuals who have a personal or family history suggestive of high lung cancer risk.
EXPLORATORY OBJECTIVES:
I. To assess the frequency of abnormal radiographic findings in high-risk individuals unaffected with cancer who undergo low-dose computed tomography (CT) screening.
II. Use patient survey and medical record data to explore the associations between social determinants of health, biological risk factors, family history and lung cancer incidence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have had clinical germline genetic testing and/or have consented or expressed a willingness to consent to the City of Hope (COH) General Research Protocol COH IRB # 07047
- •Age >= 18 years
- •Willing to have about 30 mL of blood (approximately 2 tablespoons) drawn during the aspiration visit
- •Speak English, Spanish, or Mandarin
- •Lung cancer patients: meeting at least one of the following criteria:
- •Be a never-smoker with lung cancer (excludes atypical/typical carcinoid and small cell tumors)
- •Be diagnosed with lung cancer =< 50 years of age
- •Have a germline alteration known/suspected to be associated with elevated lung cancer risk
- •Have a strong family history of lung cancer (>= one first, second or third degree relative with never-smoking lung cancer, >= three first, second or third degree relative with lung cancer in one lineage [side of the family], >= one first, second or third degree relative diagnosed with lung cancer under the age of
- •Patients may also be considered eligible if they meet the family history criteria in part and have a truncated family structure [e.g., only one first and one second degree relative with lung cancer in a small family])
- •Unaffected patients (i.e., those without a lung cancer diagnosis and other cancer diagnosis for the past 5 years) who are at least 50 years of age or at most age 10 years younger than the first case of lung cancer in the family, meeting at least one of the following criteria:
- •Have a germline alteration known/suspected to be associated with elevated lung cancer risk
- •Have a strong family history of lung cancer (>= one first, second or third degree relative with never-smoking lung cancer, >= three first, second or third degree relative with lung cancer in one lineage [side of the family], >= one first, second or third degree relative diagnosed with lung cancer under the age of
- •Patients may also be considered eligible if they meet the family history criteria in part and have a truncated family structure [e.g., only one first and one second degree relative with lung cancer in a small family])
- •Of East Asian descent with any family history of lung cancer
- •Documented informed consent of the participant
排除标准
- •Unable to provide informed consent
- •Patients who fall under the unaffected cohort criteria but received chest imaging (except chest x-ray) within the last year
研究组 & 干预措施
Observational (survey, biospecimen, medical record, CT)
Participants complete a survey over 40-45 minutes at baseline. Participants' medical records are also reviewed. Participants who have lung cancer but have not undergone treatment and participants not diagnosed with lung cancer (i.e., "unaffected"), undergo collection of blood samples at a scheduled clinical or research blood draw. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose CT scan over 20 minutes.
干预措施: Biospecimen Collection (Procedure)
Observational (survey, biospecimen, medical record, CT)
Participants complete a survey over 40-45 minutes at baseline. Participants' medical records are also reviewed. Participants who have lung cancer but have not undergone treatment and participants not diagnosed with lung cancer (i.e., "unaffected"), undergo collection of blood samples at a scheduled clinical or research blood draw. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose CT scan over 20 minutes.
干预措施: Computed Tomography (Procedure)
Observational (survey, biospecimen, medical record, CT)
Participants complete a survey over 40-45 minutes at baseline. Participants' medical records are also reviewed. Participants who have lung cancer but have not undergone treatment and participants not diagnosed with lung cancer (i.e., "unaffected"), undergo collection of blood samples at a scheduled clinical or research blood draw. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose CT scan over 20 minutes.
干预措施: Electronic Health Record Review (Other)
Observational (survey, biospecimen, medical record, CT)
Participants complete a survey over 40-45 minutes at baseline. Participants' medical records are also reviewed. Participants who have lung cancer but have not undergone treatment and participants not diagnosed with lung cancer (i.e., "unaffected"), undergo collection of blood samples at a scheduled clinical or research blood draw. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose CT scan over 20 minutes.
干预措施: Survey Administration (Other)
结局指标
主要结局
Frequency of germline alterations
时间窗: Through study completion, an average of 5 years
We will explore the relationships between variables, examining correlations (Pearson or Spearman where appropriate). Summarization of data using univariate distributions of the outcomes of interest (presence of lung cancer and molecular phenotypes) and their bivariate distributions with social determinants of health will be carried out. We will examine whether financial hardship, low levels of education, and traffic proximity are associated with presence of lung cancer and molecular phenotypes by using T-tests to compare means and Fisher's exact test to compare proportions. We will also conduct logistic regression modeling to adjust for relevant covariates like race/ethnicity, age, and sex. If appropriate, we will use standard techniques such as sensitivity analyses or multiple imputation to handle missing data.
次要结局
未报告次要终点