Clinical trial · Observational
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Individuals with elevated-risk lung cancer (screening population)
- interventionNames
- Other: Blood Sample Collection
Primary outcomes (1)
- measure
- Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
- timeFrame
- Approximately 24 months
Secondary outcomes (2)
- measure
- Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
- timeFrame
- Up to approximately 36 months
- measure
- Adverse events (AEs) associated with the blood specimen collection.
- timeFrame
- Point in time blood collection (1 day) at enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects 1. Ability to understand and provide written informed consent 2. Age ≥ 50 years 3. Current or former smoker 4. ≥ 20 pack-years (pack years = number of packs per day × number of years smoked) 5. An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan) Exclusion Criteria: * All subjects 1. Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment 2. Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies) 3. Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment 4. Any history of organ tissue transplantation 5. Any history of blood product transfusion within 120 days prior to enrollment 6. Current pregnancy 7. Any condition that in the opinion of the Investigator should preclude the participant's participation in the study 8. Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics
References
Publications (0)
Data not yet available