Last reviewed · How we verify
NCT05306288: DELFI-L201
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
trial testing Blood Sample Collection in Lung Cancer in 11,935 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2026
Quick facts
| Lead sponsor | Delfi Diagnostics Inc. |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 11,935 |
| Start date | 7 April 2022 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 October 2026 |
| Sites | 67 locations across Puerto Rico, United States |
Drugs / interventions tested
- Blood Sample Collection — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
Delfi Diagnostics Inc. — full company profile →
Who can join
50 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to demonstrate the performance characteristics, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DELFI Lung Cancer Screening Test (DLCST) for the detection of pathologically-confirmed lung cancer in a screening population using LDCT, pathology, and follow-up as the reference method.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cell-free DNA approaches for cancer early detection and interception.
Medina JE, Dracopoli NC, Bach PB, Lau A, et al · · 2023 · cited 64× · PMID 37696619 · DOI 10.1136/jitc-2022-006013 -
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 -
Screening for pancreatic cancer has the potential to save lives, but is it practical?
Mazer BL, Lee JW, Roberts NJ, Chu LC, et al · · 2023 · cited 23× · PMID 37212770 · DOI 10.1080/17474124.2023.2217354 -
Blood microRNA testing in participants with suspicious low-dose CT findings: follow-up of the BioMILD lung cancer screening trial.
Boeri M, Sabia F, Ledda RE, Balbi M, et al · · 2024 · cited 11× · PMID 39319217 · DOI 10.1016/j.lanepe.2024.101070 -
Exploring the Potential of Non-Coding RNAs as Liquid Biopsy Biomarkers for Lung Cancer Screening: A Literature Review.
Garbo E, Del Rio B, Ferrari G, Cani M, et al · · 2023 · cited 11× · PMID 37835468 · DOI 10.3390/cancers15194774 -
Brave new world of cfDNA-omics for early cancer detection.
Rolfo C, Russo A. · · 2023 · cited 11× · PMID 37696620 · DOI 10.1136/jitc-2022-006309 -
Cancer Screening: Present Recommendations, the Development of Multi-Cancer Early Development Tests, and the Prospect of Universal Cancer Screening.
Galeș LN, Păun MA, Anghel RM, Trifănescu OG. · · 2024 · cited 9× · PMID 38539525 · DOI 10.3390/cancers16061191 -
Emerging Strategies in Lung Cancer Screening: Blood and Beyond.
Bhalla S, Yi S, Gerber DE. · · 2024 · cited 8× · PMID 38175587 · DOI 10.1093/clinchem/hvad137
Verify or expand the search:
- PubMed search for NCT05306288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Delfi Diagnostics Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05306288 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Delfi Diagnostics Inc.
- Last refreshed: 19 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05306288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing