Clinical trial · Observational
Lung EpiCheck Biomarkers Development Study
NCT06245876CI-TRIAL-00073920unknownClinicalTrials.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 of a non-invasive lung cancer 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 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cases Cohort
- description
- Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects.
- interventionNames
- Other: Blood collection
- label
- USPSTF At Risk - Control Cohort
- description
- Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years.
- interventionNames
- Other: Blood collection
- label
- Healthy Control Cohort
- description
- Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria - Cases: * Age 50-80 years * Subjects who are currently smoking or former smokers, with at least 20 pack-years * Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology. Exclusion Criteria - Cases * Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer Inclusion Criteria - USPSTF risk * Age 50-80 years * Subjects who are currently smoking or former smokers, with at least 20 pack-years Exclusion Criteria - USPSTF risk \- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix Inclusion Criteria - Healthy controls * Age 20-80 years * Never smoker or current / previous smoker \< 20 pack year history Exclusion Criteria - Healthy Controls * Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix. * Not previously diagnosed with a lung lesion highly suspicious for cancer * Under follow up or work up for any lesion suspicious for any type of cancer * Presenting with fever with body temperature 100.4°F (38°C) or higher * Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw * Pregnancy * Any history of blood product transfusion within 30 days prior to blood draw
References
Publications (0)
Data not yet available
No reference posted for this study.