Clinical trial · Observational
Specimens for Lung Cancer Panel Design
NCT07401797CI-TRIAL-00102866recruitingClinicalTrials.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 is an observational study designed to determine the optimal combination of biomarkers and clinical data for the early detection, confirmation, and better treatment of lung cancer including minimizing recurrence.
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 Nodules | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Prior cancer
- description
- Prior cancer history
- label
- No prior cancer
- description
- Indeterminant lung nodules with no prior history of cancer
- label
- Healthy volunteers
- description
- Healthy volunteers
Primary outcomes (1)
- measure
- Test performance
- timeFrame
- Two years from final case enrollment
- description
- Analytical validity, clinical validity, and clinical utility. Ability to correctly re-risk indeterminate nodules and ability to change clinical care based on hypothetical treatment plans for different test outcomes. Actual test results will not be provided to physicians, and actual care will not be affected.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
6.1 Criteria for the no prior cancer suspicious nodule arm Inclusion: 1. The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery. 2. The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months. 3. Ability to understand the study and sign an informed consent form 4. Relevant clinical data accessible 5. Ability and willingness to safely donate 40 mL of blood 6. Ability of the site to collect and process blood per protocol Exclusion 1\. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater. 2\. The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary. 3\. Previous cancer diagnosis of any origin. 4. Is currently pregnant 5. Is currently a prisoner or becomes a prisoner at any point during the study 6. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf 6.2 Criteria for the previous cancer suspicious nodule arm Inclusion: 1\. The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery. 2\. The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months. 3\. The patient has been in remission for a previous cancer not of lung origin for more than 5 years. 4\. Ability to understand the study and sign an informed consent form 5. Relevant clinical data accessible 6. Ability and willingness to safely donate 40 mL of blood 7. Ability of the site to collect and process blood per protocol Exclusion 1. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater. 2. The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary. 3. Previous cancer diagnosis in the lung (either of lung origin or metastasis to the lung). 4. The treating physician believes the lung nodule is a recurrence of a previously diagnosed cancer. 5. Is currently pregnant 6. Is currently a prisoner or becomes a prisoner at any point during the study 7. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf 6.3 Criteria for the healthy volunteer arm Inclusion: 1. Ability to understand the study and sign an informed consent form 2. Relevant clinical data accessible 3. Ability and willingness to safely donate up to 40 mL of blood 4. The ability of the site to collect and process blood per protocol Exclusion 1\. Is currently pregnant 2. Is currently a prisoner or becomes a prisoner at any point during the study 3. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf
References
Publications (0)
Data not yet available
No reference posted for this study.