Clinical trial NCT01587573: Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer
Official title: Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Squamous Cell Carcinoma
Keywords: salivary biomarkers
Lead sponsor: PeriRx
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test specificity at 90% sensitivity
timeFrame: at study completion as well as after model development following enrollment of the first 30 patents with cancer
Secondary outcomes:
measure: Validation of individual mRNA and protein markers
timeFrame: After enrollment of 30 patients with cancer
measure: Validation of a pre-specified multi marker model
timeFrame: After enrollment of 30 patients with cancer
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Lansing
country: United States
facility: Department of Surgery, Michigan Sate University
state: Michigan
city: Warren
country: United States
facility: St. John Providence Health System
state: Michigan
city: Wynnewood
country: United States
facility: Main Line Health System
state: Pennsylvania
Study officials:
affiliation: PeriRx, LLC
name: Jack L Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Main Line Health System
name: Marc Surkin, MD
role: STUDY_CHAIR
References:
citation: Martin JL. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort. PLoS One. 2016 Jul 13;11(7):e0158462. doi: 10.1371/journal.pone.0158462. eCollection 2016.