ctDNA Assay for Lung Cancer
(EQUAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new blood test designed to detect early signs of EGFR-positive lung cancer. It targets healthy individuals at risk for lung cancer who cannot undergo regular screening. The test, known as a circulating free DNA (cfDNA) assay, searches for small DNA fragments in the blood that might indicate cancer. This trial suits non-smokers who are East Asian or Hispanic/Latinx and either have a family history of this lung cancer type or have recently experienced certain lung-related symptoms. Participants will provide blood samples and may join surveys or focus groups about their experiences. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier lung cancer detection.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What prior data suggests that this ctDNA assay is safe for screening lung cancer?
Research shows that the blood test under study, known as a circulating tumor DNA (ctDNA) assay, is generally easy for people to handle. This test involves taking a small blood sample to examine tiny pieces of DNA in the blood. Previous studies have found this method to be a safe and effective way to monitor cancer without harming patients. As it is just a blood test, it carries no major risks or side effects. This type of test is already used in some cancer treatments to help doctors assess disease progression or response to treatment. Overall, the ctDNA test is considered safe for participants.12345
Why are researchers excited about this trial?
Unlike the standard lung cancer screening methods, which typically involve imaging tests like CT scans, the ctDNA assay is a blood test that detects circulating tumor DNA. This approach is less invasive and could potentially catch cancer earlier by identifying genetic changes in the blood before tumors are visible on scans. Researchers are excited about this technique because it offers a non-invasive, quicker way to monitor for lung cancer, which could lead to earlier interventions and better outcomes for patients.
What evidence suggests that this ctDNA assay is effective for screening EGFR positive lung cancer?
Research has shown that a circulating free DNA (cfDNA) assay, or liquid biopsy, could help detect lung cancer early. This trial will use the investigational ctDNA assay to identify changes in tumor DNA in the blood, potentially finding cancer before symptoms appear. In lung cancer cases, this test has effectively detected small amounts of cancer that might remain after treatment. It also enables doctors to quickly identify important signs of lung cancer, allowing for faster customization of treatments. Overall, cfDNA tests are becoming a reliable method for early cancer detection and monitoring.26789
Who Is on the Research Team?
Narjust Florez, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for healthy Asian and Latinx individuals at risk of lung cancer who can't have standard screening. It's looking to detect EGFR mutations, which are linked to certain lung cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Blood Sample Collection and Testing
Participants provide blood samples for the ctDNA assay and complete a baseline questionnaire. Positive results are followed by CLIA verification and potentially a lung CT scan.
Follow-up
Participants with positive results are monitored through additional testing and scans. Negative CT scans are followed by a repeat scan in 12 months.
Optional Studies
Participants may participate in optional studies including a one-time survey, virtual focus group, and blood banking study.
What Are the Treatments Tested in This Trial?
Interventions
- Circulating free DNA (cfDNA) Assay
Trial Overview
The study tests a new blood test called Circulating Tumor DNA (ctDNA) Assay, designed to screen for EGFR positive lung cancer in people without symptoms.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborator
Boston Medical Center
Collaborator
Massachusetts General Hospital
Collaborator
Published Research Related to This Trial
Citations
Predictive Effectiveness of Circulating Tumor DNA in ...
These results highlight the potential of ctDNA MRD testing to enhance postoperative surveillance and guide personalized disease management in ...
Circulating tumor DNA to monitor treatment response in ...
In this review, we provide a comprehensive, up-to-date summary of ctDNA in monitoring treatment response with a focus on lung, colorectal, and breast cancers.
Longitudinal ultrasensitive ctDNA monitoring for high ...
“Liquid biopsy” of circulating tumor DNA (ctDNA) has emerged as a promising non-invasive approach for detection and risk profiling of malignant ...
ctDNA can detect minimal residual disease in curative ...
Detection of circulating tumor DNA (ctDNA) in plasma has been shown across various cancer types to effectively stratify patients into low- and high-risk groups ...
Association of Circulating Tumor DNA Testing Before ...
The use of plasma ctDNA testing before tissue diagnosis among patients with suspected advanced lung cancer may expedite biomarker testing and accelerate time ...
Clinical Utility of ctDNA Analysis in Lung Cancer—A Review
This review discusses current and future potential directions for the development and implementation of ctDNA for patients with NSCLC.
Circulating tumor DNA as liquid biopsy in lung cancer
Circulating tumor DNA (ctDNA), an ideal biomarker of liquid biopsy, has emerged as one of the most reliable tools for monitoring tumor processes at molecular ...
Comprehensive Genomic Analysis of Patients With Non ...
NGS ctDNA analysis in comprehensive genetic testing improves actionable mutation identification, vital for treating Asian NSCLC cases with high actionable ...
Reporting of molecular test results from cell-free DNA ...
Reporting of molecular test results from cell-free DNA analyses: expert consensus recommendations from the 2023 European Liquid Biopsy Society ctDNA Workshop.
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