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

April 10, 2018 updated by: PeriRx

Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • University of Illinois at Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Terminated
        • University of Michigan
      • East Lansing, Michigan, United States, 48912
        • Terminated
        • Department of Surgery, Michigan Sate University
      • Warren, Michigan, United States, 48092
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Main Line Health System
        • Contact:
          • Marc Surkin, MD
          • Phone Number: 610-446-6900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at study completion as well as after model development following enrollment of the first 30 patents with cancer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of individual mRNA and protein markers
Time Frame: After enrollment of 30 patients with cancer
Based on comparison of cancer and controls
After enrollment of 30 patients with cancer
Validation of a pre-specified multi marker model
Time Frame: After enrollment of 30 patients with cancer
Based on combined sensitivity and specificity
After enrollment of 30 patients with cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriRx

Investigators

  • Principal Investigator: Jack L Martin, MD, PeriRx, LLC
  • Study Chair: Marc Surkin, MD, Main Line Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PeriRx-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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