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Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01587573
Recruitment Status : Unknown
Verified May 2017 by PeriRx.
Recruitment status was:  Recruiting
First Posted : April 30, 2012
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

Condition or disease Intervention/treatment
Oral Squamous Cell Carcinoma Other: saliva collection prior to clinically driven oral biopsy

Detailed Description:
Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.

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Study Type : Observational
Estimated Enrollment : 370 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma
Actual Study Start Date : April 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
oral lesions
oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy
Other: saliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

Primary Outcome Measures :
  1. Test specificity at 90% sensitivity [ Time Frame: at study completion as well as after model development following enrollment of the first 30 patents with cancer ]
    Based on multimarker test score

Secondary Outcome Measures :
  1. Validation of individual mRNA and protein markers [ Time Frame: After enrollment of 30 patients with cancer ]
    Based on comparison of cancer and controls

  2. Validation of a pre-specified multi marker model [ Time Frame: After enrollment of 30 patients with cancer ]
    Based on combined sensitivity and specificity

Biospecimen Retention:   Samples With DNA
cell free saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy

Inclusion Criteria:

  • Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer

Exclusion Criteria:

  • Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01587573

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United States, Illinois
University of Illinois at Chicago Withdrawn
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan Terminated
Ann Arbor, Michigan, United States, 48109
Department of Surgery, Michigan Sate University Terminated
East Lansing, Michigan, United States, 48912
St. John Providence Health System Recruiting
Warren, Michigan, United States, 48092
Contact: Michael Shaw, PhD    248-967-7791   
Principal Investigator: Harvey Zalesin, DDS         
Principal Investigator: Paul Hoff, MD         
United States, Pennsylvania
Main Line Health System Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Marc Surkin, MD    610-446-6900      
Sponsors and Collaborators
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Principal Investigator: Jack L Martin, MD PeriRx, LLC
Study Chair: Marc Surkin, MD Main Line Health System

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PeriRx Identifier: NCT01587573    
Other Study ID Numbers: PeriRx-1
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by PeriRx:
salivary biomarkers
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell