Salivary Biomarkers for Non-small Cell Lung Cancer Detection

Status unconfirmed

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT02294578

Run by

PeriRx

People needed

166

Starts

2014-12-01

Expected to finish

2019-03-01

Last updated by the study team

2018-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. John Macomb-Oakland Hospital — Warren, Michigan, United States (enrolling)
• Main Line Health Ststem — Wynnewood, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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