DNA Screening Test Education for Lung Cancer Detection

(FIRSTLUNG Trial)

No longer recruiting at 2 trial locations

Overseen By Kendall Kirsch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Delfi Diagnostics Inc.

Disqualifiers: Other DELFI studies, Other biomarker studies

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new DNA-based test, FirstLook™ (also known as the DELFI Lung Cancer Screening Test), can increase lung cancer screening rates. It focuses on individuals who should be screened for lung cancer but are not up to date with their tests. The trial compares different methods for doctors' practices to use this test, including providing some with special training. Current or former smokers with a significant smoking history who haven't had a recent lung screening might be suitable participants. The goal is to determine if the availability of this test makes screening more accessible. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance lung cancer screening accessibility.

Will I have to stop taking my current medications?

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

What prior data suggests that the DELFI Lung Cancer Screening Test is safe?

Research has shown that the DELFI Lung Cancer Screening Test, known as FirstLook™, helps detect lung cancer early. It uses a simple blood test to identify DNA changes linked to lung cancer. While studies highlight its accuracy in detecting cancer, they do not specifically address safety concerns. However, as a blood test, it is generally easy to manage and poses less risk than other medical procedures. Available data have reported no major negative effects from the test, suggesting it should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DELFI Lung Cancer Screening Test because it represents a novel approach to early lung cancer detection. Unlike traditional methods that often rely on imaging techniques like CT scans, DELFI uses a DNA-based screening approach to detect cancerous changes. This test analyzes genetic material from blood samples, potentially offering a less invasive and more accessible option for early detection. By improving early diagnosis, DELFI could lead to better outcomes for patients, which is why the medical community is eagerly watching its development.

What evidence suggests that the DELFI Lung Cancer Screening Test is effective for increasing lung cancer screening rates?

In this trial, participants in Arm B will receive education on the DELFI's FirstLook Lung test. Previous studies have shown promise by identifying changes in DNA pieces linked to lung cancer through a simple blood test. Research indicates that this test can detect these changes with high accuracy, allowing for early detection of lung cancer. Early findings suggest that when doctors use this test, more patients undergo lung cancer screening. This is crucial because early detection can lead to quicker treatment and improved outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter Bach, MD

Principal Investigator

Chief Medical Officer

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Continuing Medical Education for Lung Cancer
• DELFI Lung 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.

How Is the Trial Designed?

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.

DELFI Lung Cancer Screening Test is already approved in United States for the following indications:

Approved in United States as FirstLook Lung for:

• Lung cancer screening for individuals eligible based on USPSTF guidelines

Who Is Running the Clinical Trial?

Delfi Diagnostics Inc.

Lead Sponsor

Trials

3

Recruited

17,800+

Published Research Related to This Trial

Liquid biopsy (LB) is a promising noninvasive tool for early detection of lung cancer, potentially improving outcomes compared to current screening methods like low-dose computed tomography (LDCT).

This systematic review evaluates the sensitivity and specificity of LB tests for lung cancer detection, addressing its accuracy across different populations, including never and light smokers, which is crucial for broadening screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid Biopsy Screening for Early Detection of Lung Cancer: Current State and Future Directions. Zhu, W., Love, K., Gray, SW., et al.[2023]

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]

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]

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]

Citations

1. delfidiagnostics.com delfidiagnostics.com/healthsystems/

Health Systems - DELFI DELFI's FirstLook Lung test identifies genome-wide alterations associated with lung cancer at high sensitivity using a simple blood draw.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11355097/

Innovations in Early Lung Cancer Detection This review assesses the screening landscape, explores obstacles to lung cancer screening, and discusses how a plasma whole genome fragmentome test (pWGFrag- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06145750?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Delfi%20Diagnostics%20Inc.%22))&rank=1

NCT06145750 | Implementing Fragmentomics Into Real ... DELFI hypothesized that patients in the care of physicians or practice groups who have FirstLook™ will have increased lung screening rates compared to patients ...

4. prnewswire.com prnewswire.com/news-releases/landmark-blood-based-ai-lung-cancer-screening-test-study-results-published-in-cancer-discovery-302162028.html

Landmark Blood-Based AI Lung Cancer Screening Test ... The report details the performance and potential of DELFI's FirstLook Lung test. This milestone study, led by top researchers in the field, ...

5. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/U01CA271896

DNA evaluation of fragments for early interception (DELFI) of ... The purpose of our proposed research is to study the origins and molecular characteristics of cell-free DNA fragments along the progression of Lung Cancer.

6. clpmag.com clpmag.com/disease-states/cancer/lung-cancer/delfi-diagnostics-blood-test-validated-for-early-lung-cancer-detection/

DELFI Diagnostics' Blood Test Validated for Early Lung ... DELFI's blood-based Lung test has been clinically validated to enhance early detection of lung cancer, demonstrating high sensitivity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9196057/

Advances in lung cancer screening and early detection - PMC The 5-year survival rate of early stage lung cancer can be increased by 20%–30% through radical surgery, but approximately 85% of patients with lung cancer are ...