EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- Detection Rate of Non-Small Cell Lung Cancer
研究概览
简要总结
This research study is studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease and who cannot undergo regular lung cancer screening.
The name of the test used in this research study is:
-Circulating free DNA (cfDNA) Assay
详细描述
The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group.
It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Aims 1, 2, and 3) for Group 1 (50 through 80 years of age):
- •Non-tobacco using (currently)
- •Self-identify as East Asian (including Southeast Asian) or Hispanic/Latinx.
- •East Asian includes those who self-identify as Chinese, Japanese, Korean, Taiwanese, Malaysian
- •Southeast Asian includes those who self-identify as Cambodian, Thai, Vietnamese, Filipino
- •Latinx includes those who self-identify as a person of Central or South American and the Caribbean including, Cuban, Puerto Rican, and Dominican culture or origin, excluding individuals originating from Spain
- •Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
- •Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.
- •Inclusion Criteria (Aims 1, 2, and 3) for Group 2 (40 through 49 years of age):
- •Non-tobacco using (currently)
- •Self-identify as East Asian (including Southeast Asian) or Latinx, if any of the following criteria are met:
- •Family history of EGFR positive LC L858R or exon 19
- •Personal history of remote cancer that is not LC or other thoracic malignancies, including thymoma, thymic carcinoma, or sarcoma, as long as it was resolved over 5 years ago
- •History of TB, asthma requiring daily inhaled corticosteroids or chronic bronchitis
- •Symptoms of lung cancer for the past month, including hemoptysis, unexplained weight loss, voice hoarseness, cough or worsening cough, dyspnea or worsening dyspnea
- •Excluding individuals who concurrently present with fever, covid/influenza/RSV/adenovirus infection, runny nose, sore throat, productive cough with green or yellow sputum
- •Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean
- •Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.
排除标准
- •(Aims 1, 2, and 3) for Groups 1 and 2:
- •Having had a chest CT scan in the last 3 years or having an anticipated chest CT scan during the enrollment period.
- •Having a current cancer or history of cancer within the last 5 years, excluding localized non-melanoma skin cancer and breast ductal carcinoma in situ.
- •More than 400 lifetime cigarettes (i.e., 20 packs) of smoking or tobacco use
- •Adults unable to provide informed consent
- •Individuals <40 years of age
- •Prisoners
- •Pregnant women
- •Personal diagnosis of lung cancer
- •Not able to be compliant with study requirements
研究组 & 干预措施
ctDNA Assay
All participants will be asked to provide blood samples and are administered a baseline questionnaire. The blood sample will be tested using the investigational ctDNA assay. If the investigational test is positive, these participants will be followed up by CLIA verification of results. A positive CLIA result will be followed up by a lung CT scan. A positive CT scan will be followed up by referral for further evaluation. A negative CT scan will be followed up by a repeat scan in 12 months. Participants will be notified of results.
Additionally, participants may participant in optional studies: 1) One-time survey regarding perception of lung cancer screening and ctDNA testing, 2) Virtual focus group, 3) Blood banking study
干预措施: Circulating Tumor DNA (ctDNA) Assay (Device)
结局指标
主要结局
Detection Rate of Non-Small Cell Lung Cancer
时间窗: 2 years
The proportion of participants with a positive assay result who are subsequently diagnosed with lung cancer through clinical pathology, among all participants tested with the assay.
次要结局
- Barriers to Sample Acquisition(Up to 2 years)
- Testing Turnaround Time(Up to 2 years)
- Recruitment Acceptability(Up to 2 years)
研究者
Narjust Florez
Principal Investigator
Dana-Farber Cancer Institute