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

PeriRx370 enrolled

Overview

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.

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

370

Conditions

Oral Squamous Cell Carcinoma

Interventions

saliva collection prior to clinically driven oral biopsyOTHER

cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Illinois at Chicago

Chicago, Illinois, United States

WITHDRAWN

University of Michigan

Ann Arbor, Michigan, United States

TERMINATED

Department of Surgery, Michigan Sate University

East Lansing, Michigan, United States

TERMINATED

Outcomes

Primary Outcomes

Test specificity at 90% sensitivity

Based on multimarker test score

Time frame: at study completion as well as after model development following enrollment of the first 30 patents with cancer

Secondary Outcomes

Validation of individual mRNA and protein markers

Based on comparison of cancer and controls

Time frame: After enrollment of 30 patients with cancer

Validation of a pre-specified multi marker model

Based on combined sensitivity and specificity

Time frame: After enrollment of 30 patients with cancer

Data from ClinicalTrials.gov

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