Salivary Biomarkers for Non-small Cell Lung Cancer Detection
Prospective Blinded Evaluation of Salivary Transcriptome Biomarkers for Non-small Cell Lung Cancer Detection
1 other identifier
observational
166
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 12, 2018
April 1, 2018
4 years
November 5, 2014
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene)
Multi-marker test score conmined sensitivity abd specificity
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.
Secondary Outcomes (3)
Validation of the individual mRNA biomarkers (BRAF, CCN1, EGRF, FGF19, FRS2,GREB1 and LZTS1)
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.
Performance of new multi-marker models
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.
Performance of new candidate housekeeping genes
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.
Study Arms (2)
Lung Cancer
Patients with biopsy proven lung cancer
Controls
Patients with lung lesions suspicious for the presence of cancer and with cancer excluded after further diagnostic study
Eligibility Criteria
Adult patients presenting for evaluation of lung lesions suspicious for the presence of lung cancer.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PeriRxlead
Study Sites (2)
St. John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Main Line Health Ststem
Wynnewood, Pennsylvania, 19096, United States
Biospecimen
Saliva samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jack L Martin, MD
PeriRx, LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Medical Officer
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 19, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
April 12, 2018
Record last verified: 2018-04