EGFR Gene Mutation, Lung Cancer
Conditions
Keywords
Lung Cancer, EGFR Gene Mutation, EGFR-related lung cancer, EGFR positive lung cancer
Brief summary
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
Detailed description
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.
Interventions
DEVICECirculating Tumor DNA (ctDNA) Assay
Screening investigational blood test to test for EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. A positive or indeterminate investigational test will be followed up by CLIA verification of results. A positive or indeterminate 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.
Sponsors
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Boston Medical Center
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
(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.
Exclusion criteria
(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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Non-Small Cell Lung Cancer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Testing Turnaround Time | Up to 2 years | The duration from the time of blood draw to the release of the ctDNA testing results to the study team. |
| Recruitment Acceptability | Up to 2 years | Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site |
| Barriers to Sample Acquisition | Up to 2 years | Examining barriers impeding scale-up of sample collection, handling, and delivery |
Countries
United States
Contacts
CONTACTFernando Pacheco
CONTACTKylee Coonradt
PRINCIPAL_INVESTIGATORNarjust Florez, MD
Dana-Farber Cancer Institute
Outcome results
None listed