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NCT06145750: FIRSTLUNG

Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer

Completed NA Last updated 24 November 2025
What this trial tests

NA trial testing Ability to order FirstLook™ in Lung Cancer in 28 participants. Completed in 31 August 2025.

Timeline
31 October 2023
Primary endpoint
31 August 2025
31 August 2025

Quick facts

Lead sponsorDelfi Diagnostics Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposescreening
Enrollment28
Start date31 October 2023
Primary completion31 August 2025
Estimated completion31 August 2025
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Delfi Diagnostics Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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™.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical Validation of a Cell-Free DNA Fragmentome Assay for Augmentation of Lung Cancer Early Detection.
    Mazzone PJ, Bach PB, Carey J, Schonewolf CA, et al · · 2024 · cited 57× · PMID 38829053 · DOI 10.1158/2159-8290.cd-24-0519
  2. Exploring the clinical utility of liquid biopsy with cfDNA in cancer: A systematic review.
    Ranganathan K, Kurian NS, Goswami HM, Rishi KD, et al · · 2024 · cited 5× · PMID 40027943 · DOI 10.1016/j.jlb.2024.100150
  3. Minimally invasive biomarkers for triaging lung nodules-challenges and future perspectives.
    Afridi WA, Picos SH, Bark JM, Stamoudis DAF, et al · · 2025 · cited 5× · PMID 39888565 · DOI 10.1007/s10555-025-10247-5
  4. Innovations in Early Lung Cancer Detection: Tracing the Evolution and Advancements in Screening.
    Cotton LB, Bach PB, Cisar C, Schonewolf CA, et al · · 2024 · cited 5× · PMID 39201053 · DOI 10.3390/jcm13164911

Verify or expand the search:

Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

Other Delfi Diagnostics Inc. trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing