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

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01587573
• Other study ID #: PeriRx-1
• Status: Recruiting
• First received: April 26, 2012
• Last updated: April 10, 2018
• Start date: April 2012
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: PeriRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma

Intervention

Other:
• saliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Department of Surgery, Michigan Sate University	East Lansing	Michigan
United States	St. John Providence Health System	Warren	Michigan
United States	Main Line Health System	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
PeriRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test specificity at 90% sensitivity	Based on multimarker test score	at study completion as well as after model development following enrollment of the first 30 patents with cancer
Secondary	Validation of individual mRNA and protein markers	Based on comparison of cancer and controls	After enrollment of 30 patients with cancer
Secondary	Validation of a pre-specified multi marker model	Based on combined sensitivity and specificity	After enrollment of 30 patients with cancer