Clinical trial · Observational
Identification of a Plasma Proteomic Signature for Lung Cancer
NCT01752101CI-TRIAL-00016572completedClinicalTrials.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 is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.
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 |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Precancerous Conditions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence rate of Non-Small Cell Lung Cancer
- timeFrame
- 24 months after enrollment
- description
- The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.
Secondary outcomes (1)
- measure
- Panel of proteins
- timeFrame
- At the end of the study
- description
- The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 40 * any smoking status, e.g. current, former, or never * co-morbid conditions, e.g. COPD * Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity * Pathology: malignant - adenocarcinoma, squamous, or large cell * Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma) * Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B) * Clinical stage, Regional lymph nodes: N0 or N1 only * Clinical stage, Distant metastasis: M0 only Exclusion Criteria: * prior malignancy within 5 years of lung nodule diagnosis * No nodule size available * No pathology data available for those with * Current diagnosis of non-small cell lung cancer * Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1
References
Publications (2)
- DERIVEDKearney P, Hunsucker SW, Li XJ, Porter A, Springmeyer S, Mazzone P. An integrated risk predictor for pulmonary nodules. PLoS One. 2017 May 17;12(5):e0177635. doi: 10.1371/journal.pone.0177635. eCollection 2017. PMID 28545097
- DERIVEDVachani A, Hammoud Z, Springmeyer S, Cohen N, Nguyen D, Williamson C, Starnes S, Hunsucker S, Law S, Li XJ, Porter A, Kearney P. Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules. Lung. 2015 Dec;193(6):1023-7. doi: 10.1007/s00408-015-9800-0. Epub 2015 Sep 16. PMID 26376647