Recruiting

Salivary Biomarkers

Sponsor:

PeriRx

Code:

NCT02294578

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT02294578

Start date

Dec, 2014

Status verified date

Apr, 2018

Completion date

Mar, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

166 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Jack L Martin, MD

610 544 3500Martinj@mlhs.org

Stephen M Swanick, MS

610 544 3500perirx@rcn.com

Locations

St. John Macomb-Oakland Hospital

Recruiting

Warren, Michigan, United States, 48093

Contacts

Shirley Ayuk Takem, DO

215-833-9637Shirley.Ayuk-Takem@stjohn.org]

Larry Tankenow, MD

586 751-8844lbt.pma@comcast.net

Main Line Health Ststem

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Tom Meyer, MD

610-642-3796

Melinda Milliken

610 642 3796

More Information

Sponsor

PeriRx

Last update posted

Apr 12, 2018

Last verified

Apr, 2018

Keywords

  • Biomarkers
  • saliva
  • mRNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by PeriRx on 2018-04-12.