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Salivary Biomarkers for Non-small Cell Lung Cancer Detection

NCT02294578 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 166

Last updated 2018-04-12

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • PeriRx

    lead INDUSTRY

Principal Investigators

  • Jack L Martin, MD · PeriRx, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02294578 on ClinicalTrials.gov