Salivary Biomarkers for Non-small Cell Lung Cancer Detection
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 12, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- PeriRx
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- St. John Macomb-Oakland HospitalWarren, Michigan
- Main Line Health StstemWynnewood, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 12, 2018. Always confirm current availability with the study team.