Clinical trial · Observational
Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules
A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
NCT04171492CI-TRIAL-00095471ALTITUDEactive 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 evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nodule Solitary Pulmonary | — | UNRESOLVED | — |
| Non-small Cell Carcinoma | Non-Small Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Open Label
- description
- Nodify XL2 results will be reported to the investigator and available to the subject.
- label
- Blinded
- description
- Nodify XL2 results will not be available to the investigative site or subject.
Primary outcomes (1)
- measure
- Lung Nodule Diagnosis
- timeFrame
- Up to 24 months
- description
- Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements 2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern 3. Subject's lung nodule of concern meets the following: * Was incidentally identified or detected during lung cancer screening * Is a solid nodule * Has maximal dimension of \> 8mm and \< 30mm 4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment 5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less Exclusion Criteria: 1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern 2. Nodule of concern is part-solid or Ground Glass Opacity (GGO) 3. Prior diagnosis of lung cancer 4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer 5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment 6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern 7. Any illness or factor that will inhibit compliance with study participation
References
Publications (0)
Data not yet available
No reference posted for this study.