Lung Cancer Clinical Trial
Official title:
Prospective Blinded Evaluation of Salivary Transcriptome Biomarkers for Non-small Cell Lung Cancer Detection
Verified date | April 2018 |
Source | PeriRx |
Contact | Jack L Martin, MD |
Phone | 610 544 3500 |
Martinj[@]mlhs.org | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 166 |
Est. completion date | March 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | St. John Macomb-Oakland Hospital | Warren | Michigan |
United States | Main Line Health Ststem | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
PeriRx |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Validation of the individual mRNA biomarkers (BRAF, CCN1, EGRF, FGF19, FRS2,GREB1 and LZTS1) | Delta Ct values based on PCR analysis comparing cancer and controls | 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 | Performance of new multi-marker models | Multi-marker test score combined sensitivity and 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 | Performance of new candidate housekeeping genes | Based on Normfinder stability | 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. |
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