Lung CancerFIRSTLUNGNCT06145750
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
A study testing Ability to order FirstLook™ and Continuing Medical Education for Lung Cancer in people with Lung Cancer, run by Delfi Diagnostics Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ability to order FirstLook™ and Continuing Medical Education for Lung Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Oct 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practice offers primary care services. Primary care services may include, but are not limited to: community health centers, academic outpatient facilities, private practices of family or general internal medicine, and Veterans Administration outpatient primary care clinics.
- Practice has a lung cancer screening population of a minimum of 50 individuals upon first review of patient records. a. Lung cancer screening eligible population is defined as meeting the 2021 USPSTF guideline recommendations (current and former smokers 50-80 years of age, 20 pack year or more smoking history, have not quit more than 15 years ago) b. Individuals have had a clinic visit in the past 12 months, and c. 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.
- Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
- The practice utilizes conveniently located phlebotomy that accepts same-day services.
Who cannot join
- Practice is currently participating in other DELFI studies.
- Practice is actively participating in any other cancer screening blood-based biomarker studies which includes return of results.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DARTNet Institute
Aurora, Colorado, 80045
Duke University
Durham, North Carolina, 27705
University Of Florida
Jacksonville, Florida, 32209
About this study
The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021 United States Preventive Services Task Force (USPSTF) but are not up to date with it. DELFI hypothesized that patients in the care of physicians or practice groups who have FirstLook™ will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to FirstLook™.
Read the detailed description
Despite compelling evidence of the benefits of lung cancer screening, rates among eligible individuals in the United States remain stubbornly low. Using a cluster randomized controlled trial, DELFI plans to evaluate whether lung screening rates can be increased if physicians and practice groups have the ability to order a validated, commercially available FirstLook™ as an initial test for eligible individuals who are not up to date with lung screening recommendations.
- Conditions
- Lung Cancer
- Being tested
- Ability to order FirstLook™, Continuing Medical Education for Lung Cancer
- Keywords
- Lung Cancer Screening, Early Diagnosis, Low Dose CT Scan, CT Scan, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Lung Diseases, Respiratory Tract Diseases, Biomarkers, Lung Cancer Prevention, Fragmentomics, CAT Scan, Early Detection, NSCLC, Adenocarcinoma, Lung Malignancy, Liquid Biopsy, LDCT
- Medical subject headings
- Lung Neoplasms, Disease, Respiratory Tract Neoplasms, Thoracic Neoplasms, Lung Diseases, Respiratory Tract Diseases, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ability to order FirstLook™Diagnostic test
Also called FirstLook™
FirstLook™ is a commercially available, validated next generation sequencing assay of plasma cell-free DNA (cfDNA) that analyzes the distribution of cfDNA fragment sizes to indicate the presence of possible lung cancer. FirstLook™ is intended to be used by a qualified healthcare provider and is not a replacement for computed tomography (CT) or low-dose computed tomography (LDCT). FirstLook™ is validated for use in individuals aged 50 to 80 who either currently or previously smoked cigarettes and accumulated 20 pack-years or more of exposure.
Continuing Medical Education for Lung CancerOther
Physician practice will receive standard education on lung cancer screening for CME credit.
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | No 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. |
| Arm A2 | Active comparator | 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. Receives: Other: Continuing Medical Education for Lung Cancer |
| Arm B | Experimental | Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion; Receives: Diagnostic Test: Ability to order FirstLook™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of practice-identified lung cancer screen-eligible individuals receiving any screening event, defined as either a screening CT (LDCT or chest CT) or FirstLook™ Lung test (FLL) blood draw during the study period in each arm.
Measured: 15 months
Secondary outcomes (3)
Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm.
Measured: 15 months
Proportion of practice-identified lung cancer screen-eligible individuals receiving a CT order and/or completed CT scan for lung cancer screening following FirstLook™ test result during the study period.
Measured: 15 months
Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start31 Oct 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Physician practices (the study participants) will be randomized 1:1:2 to Arm A1 (control), Arm A2 (Control) or Arm B (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; practices in A2 will receive standard education on lung cancer screening for Continuing Medical Education (CME) credit. Randomizing within Arm A aims to delineate the impact standard lung cancer screening education may have on utilization. Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion. A limited data set (LDS) will be extracted from the primary care practice EMRs for the study analysis.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delfi Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bach, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145750
- Sponsor's protocol ID
- DELFI-L301
- Acronym
- FIRSTLUNG
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer
- ClinicalTrials.gov ID
- NCT06145750
- Acronym / sponsor ID
- FIRSTLUNG / DELFI-L301
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer Screening, Early Diagnosis, Low Dose CT Scan, CT Scan, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Delfi Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021 United States Preventive Services Task Force (USPSTF) but are not up to date with it. DELFI hypothesized that patients in the care of physicians or practice groups who have FirstLook™ will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to FirstLook™.
Detailed description
Despite compelling evidence of the benefits of lung cancer screening, rates among eligible individuals in the United States remain stubbornly low. Using a cluster randomized controlled trial, DELFI plans to evaluate whether lung screening rates can be increased if physicians and practice groups have the ability to order a validated, commercially available FirstLook™ as an initial test for eligible individuals who are not up to date with lung screening recommendations.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Physician practices (the study participants) will be randomized 1:1:2 to Arm A1 (control), Arm A2 (Control) or Arm B (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; practices in A2 will receive standard education on lung cancer screening for Continuing Medical Education (CME) credit. Randomizing within Arm A aims to delineate the impact standard lung cancer screening education may have on utilization. Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion. A limited data set (LDS) will be extracted from the primary care practice EMRs for the study analysis.
| Arm | Type | Receives |
|---|---|---|
| Arm A1 | No 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. |
| Arm A2 | Active comparator | Other: Continuing Medical Education for Lung CancerArm 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. |
| Arm B | Experimental | Diagnostic Test: Ability to order FirstLook™Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion; |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Practice offers primary care services. Primary care services may include, but are not limited to: community health centers, academic outpatient facilities, private practices of family or general internal medicine, and Veterans Administration outpatient primary care clinics.
- Practice has a lung cancer screening population of a minimum of 50 individuals upon first review of patient records. a. Lung cancer screening eligible population is defined as meeting the 2021 USPSTF guideline recommendations (current and former smokers 50-80 years of age, 20 pack year or more smoking history, have not quit more than 15 years ago) b. Individuals have had a clinic visit in the past 12 months, and c. 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.
- Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
- The practice utilizes conveniently located phlebotomy that accepts same-day services.
Key exclusion criteria (2 listed)
- Practice is currently participating in other DELFI studies.
- Practice is actively participating in any other cancer screening blood-based biomarker studies which includes return of results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ability to order FirstLook™Also: FirstLook™FirstLook™ is a commercially available, validated next generation sequencing assay of plasma cell-free DNA (cfDNA) that analyzes the distribution of cfDNA fragment sizes to indicate the presence of possible lung cancer. FirstLook™ is intended to be used by a qualified healthcare provider and is not a replacement for computed tomography (CT) or low-dose computed tomography (LDCT). FirstLook™ is validated for use in individuals aged 50 to 80 who either currently or previously smoked cigarettes and accumulated 20 pack-years or more of exposure. | Diagnostic test | Arm B |
| Continuing Medical Education for Lung CancerPhysician practice will receive standard education on lung cancer screening for CME credit. | Other | Arm A2 |
Primary outcome
Proportion of practice-identified lung cancer screen-eligible individuals receiving any screening event, defined as either a screening CT (LDCT or chest CT) or FirstLook™ Lung test (FLL) blood draw during the study period in each arm.
Time frame: 15 months
3 secondary outcomes
Proportion of practice-identified lung cancer screen-eligible individuals receiving a screening CT scan during the study period in each arm.
Time frame: 15 months
Proportion of practice-identified lung cancer screen-eligible individuals receiving a CT order and/or completed CT scan for lung cancer screening following FirstLook™ test result during the study period.
Time frame: 15 months
Number needed to screen (NNS) with FirstLook™ to detect one additional lung cancer during the study period.
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Detection and characterization of lung cancer using cell-free DNA fragmentomesLink provided by the sponsor.
- Screening for Lung Cancer: CHEST Guideline and Expert Panel ReportLink provided by the sponsor.
- Genome-wide cell-free DNA fragmentation in patients with cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bach, MD study chair
Chief Medical Officer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ability to order FirstLook™ and Continuing Medical Education for Lung Cancer in people with Lung Cancer, run by Delfi Diagnostics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of practice-identified lung cancer screen-eligible individuals receiving any screening event, defined as either a screening CT (LDCT or chest CT) or FirstLook™ Lung test (FLL) blood draw during the study period in each arm. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.