Clinical trial · Observational
Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
NCT04968548CI-TRIAL-00096978active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.
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 collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases Series
- description
- Subjects with confirmed lung cancer diagnosis
- interventionNames
- Procedure: Blood collection
- label
- Screening Series
- description
- Subjects undergoing LDCT for lung cancer screening
- interventionNames
- Procedure: Blood collection
Primary outcomes (2)
- measure
- Collection of blood samples
- timeFrame
- 24 Months
- description
- Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria - Cases: * Current or past smokers, with at least 20 pack-years * Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients Exclusion Criteria - Cases: * Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix * Current lung cancer is known to be stage III or IV by pathology. Inclusion Criteria - Screening: \- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening Exclusion Criteria - Screening: * Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix * Subjects whose purpose of performing LDCT is for surveillance of a lung nodule
References
Publications (1)
- BACKGROUNDGaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan. PMID 33122336