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

• Conditions: Oral Squamous Cell Carcinoma
• Interventions: Other: saliva collection prior to clinically driven oral biopsy

• Registration Number: NCT01587573
• Lead Sponsor: PeriRx

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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Status Verified: 2017-05
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oral lesions	saliva collection prior to clinically driven oral biopsy	oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy

Primary Outcome Measures

Name	Time	Method
Test specificity at 90% sensitivity	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

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

Trial Locations

Locations (5)

Main Line Health System; 🇺🇸 Wynnewood, Pennsylvania, United States

Department of Surgery, Michigan Sate University; 🇺🇸 East Lansing, Michigan, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

St. John Providence Health System; 🇺🇸 Warren, Michigan, United States