ctDNA Assay for Lung Cancer

(EQUAL Trial)

Recruiting at 6 trial locations

Overseen By Narjust Florez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Current cancer, Recent cancer, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Circulating free DNA (cfDNA) Assay for lung cancer?

Research shows that analyzing cfDNA in the blood can help guide treatment decisions for lung cancer patients, especially when tumor tissue is not available. It can also be used to monitor genetic changes in the cancer, which helps in selecting the right treatment and checking for drug resistance. ^{1 2 3 4 5}

Is cfDNA testing safe for humans?

cfDNA testing is generally considered safe as it is a minimally invasive procedure, meaning it doesn't require surgery or major medical intervention. It involves analyzing DNA from a blood sample, which is a common and low-risk medical procedure. ^{6 7 8 9 10}

How is the ctDNA Assay treatment for lung cancer different from other treatments?

The ctDNA Assay for lung cancer is unique because it uses a blood test to analyze small DNA fragments from tumor cells, allowing for non-invasive monitoring of cancer progression and treatment response. This approach can identify genetic changes in the tumor without needing a traditional tissue biopsy, making it a promising tool for personalized cancer management. ^{3 4 9 11 12}

What is the purpose of this trial?

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

Research Team

Narjust Florez, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

I am 40-49 years old and can participate in a study discussion in the specified languages.

I am 40-49, don't use tobacco, and am East Asian or Latinx.

I am 40-49 years old and can understand the study's consent form.

Exclusion Criteria

I am unable to understand or sign the consent form.

I am younger than 40 years old.

I have or had cancer in the last 5 years, excluding certain types.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

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.

Up to 2 years

Multiple visits (in-person and virtual)

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.

12 months

Follow-up visits as needed

Optional Studies

Participants may participate in optional studies including a one-time survey, virtual focus group, and blood banking study.

Treatment Details

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.

Participant Groups

Group I: ctDNA Assay Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Findings from Research

Circulating cell-free DNA (cfDNA) testing is a promising minimally invasive method for managing metastatic non-small-cell lung cancer (NSCLC), offering insights into tumor heterogeneity and allowing for repeated assessments over time.

cfDNA testing can be used for various applications, including early diagnosis, monitoring treatment response, and identifying predictive markers, highlighting its potential to enhance patient management in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of circulating free DNA in the management of NSCLC. Esposito Abate, R., Pasquale, R., Fenizia, F., et al.[2019]

Standardizing the pre-analytical processes for cell-free DNA (cfDNA) testing is crucial for obtaining reliable results, especially due to the low amounts and stability of circulating tumor DNA (ctDNA).

The review provides evidence-based guidelines for pre-analytical procedures specifically for plasma EGFR variant testing, suggesting that these standardized practices can enhance the accuracy and effectiveness of cfDNA testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing. Shin, S., Woo, HI., Kim, JW., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Circulating Cell-Free DNA for Correlation with Lung Cancer Survival: A Systematic Review and Meta-Analysis. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

Cell-free circulating tumor DNA in colorectal cancer: a proof of concept with simplified methodology. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Identification and monitoring of somatic mutations in circulating cell-free tumor DNA in lung cancer patients. [2020]

4. France pubmed.ncbi.nlm.nih.gov

[Free circulating DNA as a tool for lung cancer patients management]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Large scale, prospective screening of EGFR mutations in the blood of advanced NSCLC patients to guide treatment decisions. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Revolutionizing NSCLC Diagnosis: Ultra-High-Sensitive ctDNA Analysis for Detecting Hotspot Mutations with Long-Term Stored Plasma. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The role of circulating free DNA in the management of NSCLC. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Results of a worldwide external quality assessment of cfDNA testing in lung Cancer. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dutch National Round Robin Trial on Plasma-Derived Circulating Cell-Free DNA Extraction Methods Routinely Used in Clinical Pathology for Molecular Tumor Profiling. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA for Mutation Detection and Identification of Mechanisms of Resistance in Non-Small Cell Lung Cancer. [2020]

12. Ireland pubmed.ncbi.nlm.nih.gov

The diagnostic value of circulating cell free DNA quantification in non-small cell lung cancer: A systematic review with meta-analysis. [2022]