Clinical trial · Observational
Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
2016-11: Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program
NCT03628638CI-TRIAL-000500672016-11completedClinicalTrials.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)
The primary objective of this study is to establish a control population to assess performance of an investigational diagnostic test targeting lung neoplasms.
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 |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lung Cancer Screening Patients - No Nodules
- description
- Subjects in an low dose CT screening program that present no nodules.
- interventionNames
- Other: Blood Sample Collection
- label
- Lung Cancer Screening Patients - Nodules
- description
- Subjects in an low dose CT screening program that present nodules. Additional follow-up data will be collected for up to 12 months and an additional blood sample collected
- interventionNames
- Other: Blood Sample Collection
Primary outcomes (1)
- measure
- Biomarker Identification
- timeFrame
- 27 months
- description
- Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood to detect lung cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is male or female, 50 years of age or older. 2. Subject meets one of two lung cancer screening criteria below. 1. Subject is a candidate for LDCT lung cancer screening and is scheduled for a baseline LDCT scan. There may be circumstances when a patient cannot have an LDCT scan (e.g., due to insurance issues). In these cases, it is allowable for a patient to have a CT scan in order to meet the inclusion criteria. OR 2. Subject has had previous LDCT scan(s) for lung cancer screening and the most recent LDCT scan prior to enrollment is negative for pulmonary nodules (Lung-RADS category 1, no nodules). 3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: 1. Subjects with pulmonary nodules on the most recent LDCT scan prior to enrollment (Lung-RADS category 1 nodules with specific calcifications such as complete, central, popcorn, concentric rings and fat containing nodules are excluded). 2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. 3. Prior removal of the lung, excluding percutaneous lung biopsy. 4. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
References
Publications (0)
Data not yet available
No reference posted for this study.