DNA Screening Test Education for Lung Cancer Detection

(FIRSTLungL301 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Delfi Diagnostics Inc.

Disqualifiers: Other DELFI studies, Other biomarker studies

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial aims to see if providing doctors with the FirstLook™ test increases lung cancer screening rates among patients who should be screened but aren't up to date. The test checks blood for early signs of lung cancer by analyzing DNA fragments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How is the DELFI Lung Cancer Screening Test different from other treatments for lung cancer?

The DELFI Lung Cancer Screening Test is unique because it uses a liquid biopsy, which is a noninvasive blood test that detects tiny amounts of genetic material from cancer cells, allowing for early detection of lung cancer. This method is different from traditional low-dose CT scans, as it aims to improve sensitivity and specificity in identifying early-stage lung cancer, even in individuals who are not heavy smokers. ^{1 2 3 4 5}

Research Team

Lindsey Cotton, D.O.Med.

Principal Investigator

Director, Medical Affairs

Eligibility Criteria

This trial is for primary care practices with at least 50 patients eligible for lung cancer screening based on USPSTF guidelines, but who haven't been screened in the past 15 months. Practices should offer regular services and be able to handle data tasks. They shouldn't be part of other DELFI or early cancer detection studies.

Inclusion Criteria

Practice can identify a central phlebotomy site

Individuals have not had a CT for lung cancer screening in the last 15 months

Practice can complete EMR data extraction and EDC entry during the study

Exclusion Criteria

Practice actively participates in any other early cancer detection biomarker studies

Practice is currently participating or has previously participated in other DELFI studies

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Practices in the intervention arm receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion

15 months

Control

Practices in the control arm are observed for standard lung cancer screening practices

15 months

Follow-up

Participants are monitored for the completion of lung cancer screening CTs and shared decision-making visits

15 months

Treatment Details

Interventions

• Continuing Medical Education for Lung Cancer (Behavioural Intervention)
• DELFI Lung Cancer Screening Test (Cancer Screening Test)

Trial Overview The study tests if giving doctors access to a DNA-based lung cancer screening test (DELFI) increases the number of patients getting screened compared to doctors without it. It's about seeing if this new tool can improve how often high-risk patients get checked for lung cancer.

Participant Groups

Group I: Arm B Experimental Treatment 2 Interventions

Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion;

Group II: Arm A1 Active Control 1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A1 will be observed.

Group III: Arm A2 Active Control 1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A2 will receive standard education on lung cancer screening for CME credit.

Who Is Running the Clinical Trial?

Delfi Diagnostics Inc.

Lead Sponsor

Trials

3

Recruited

17,800+

Findings from Research

Low-dose computed tomography (CT) screening for lung cancer is currently used in some countries, like the United States, but its effectiveness is limited due to issues with sensitivity and specificity.

Recent advancements in liquid biopsies, which analyze blood for cancer biomarkers such as circulating free DNA and methylation signatures, show promise for detecting early-stage lung cancers that may not yet be visible on CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid biopsy for lung cancer screening: Usefulness of circulating tumor cells and other circulating blood biomarkers. Hofman, P.[2021]

Lung cancer screening using low-dose CT (LDCT) is currently available in the United States and is being recommended for implementation in Europe within the next 18 months, according to a recent European position statement.

Pilot programs in the UK are already testing LDCT screening, highlighting the growing recognition of its potential benefits, while also addressing the challenges that need to be resolved before widespread implementation in Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT screening for lung cancer: Are we ready to implement in Europe? Balata, H., Evison, M., Sharman, A., et al.[2020]

Lung cancer is the leading cause of cancer-related deaths in Europe, highlighting the urgent need for effective secondary prevention strategies, especially for former smokers who remain at higher risk.

Recent advances in early detection and screening methods, including computerized tomography screening trials and noninvasive biomarker testing, show promise in improving lung cancer diagnosis and potentially reducing mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and early detection of lung cancer. Van't Westeinde, SC., van Klaveren, RJ.[2015]

Lung cancer is the most common cancer globally, with a high mortality rate and a 5-year survival rate of only 8% to 12% in Europe, primarily linked to smoking in 90% of cases.

Current research is exploring low-dose computed tomography as a potential screening tool for lung cancer, with five ongoing randomized controlled trials involving 133,000 participants, but until results are available, widespread screening is not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening: current situation and perspective. Guessous, I., Cornuz, J., Paccaud, F.[2022]

References

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

Liquid Biopsy Screening for Early Detection of Lung Cancer: Current State and Future Directions. [2023]

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

Liquid biopsy for lung cancer screening: Usefulness of circulating tumor cells and other circulating blood biomarkers. [2021]

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

CT screening for lung cancer: Are we ready to implement in Europe? [2020]

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

Screening and early detection of lung cancer. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lung cancer screening: current situation and perspective. [2022]