Clinical trial · Observational
Salivary Biomarkers for Non-small Cell Lung Cancer Detection
Prospective Blinded Evaluation of Salivary Transcriptome Biomarkers for Non-small Cell Lung Cancer Detection
- 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 investigators plan to recruit patients for a prospective study in patients in need of evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before diagnostic evaluation including biopsy with subsequent blinded examination of the salivary markers without knowledge of the disease status. This prospective recruitment with retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended by the National Cancer Institute for biomarker development. This process limits the selection bias that can confound retrospective studies. As the primary endpoint, a pre-specified multi-marker panel will be evaluated based on the combination of sensitivity and specificity. In addition, seven pre-specified individual candidate mRNA cancer markers and six internal reference or "housekeeping" genes will be evaluated. The performance of new multi-marker panels will also be assessed and compared with the prior pre-specified model based on sensitivity and specificity combinations as well as the area under the receiver operating characteristic curve.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Lung Cancer
- description
- Patients with biopsy proven lung cancer
- label
- Controls
- description
- Patients with lung lesions suspicious for the presence of cancer and with cancer excluded after further diagnostic study
Primary outcomes (1)
- measure
- Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene)
- timeFrame
- Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
- description
- Multi-marker test score conmined sensitivity abd specificity
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient presenting to the participating institutions of affiliated clinics for evaluation or biopsy of a lung lesion suspicious for cancer. * Patients ≥ 18 years of age * Patients willing and able to give informed consent Exclusion Criteria: * Diagnosis of cancer within the last two years, excluding non-melanoma skin cancer (if \> 2 years since diagnosis, must be free of known disease \& not on current treatment for cancer). * Prior immunosuppressive therapy or autoimmune disorder * Known HIV infection * Known Hepatitis infection
References
Publications (0)
Data not yet available