Recruiting

Oral Cancer Test

Sponsor:

PeriRx

Code:

NCT01587573

Conditions

Oral Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

saliva collection prior to clinically driven oral biopsy

Study Details

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.

Conditions

Oral Squamous Cell Carcinoma

Study ID

NCT01587573

Start date

Apr, 2012

Status verified date

May, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

370 participants

Anticipated

Interventions and Outcome Measures

Arms

oral lesions

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

Interventions

saliva collection prior to clinically driven oral biopsy

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

St. John Providence Health System

Recruiting

Warren, Michigan, United States, 48092

Contacts

Michael Shaw, PhD

248-967-7791Michael.Shaw@providence-stjohnhealth.org

Principal Investigator:

Harvey Zalesin, DDS

Main Line Health System

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Marc Surkin, MD

610-446-6900

More Information

Sponsor

PeriRx

Last update posted

Apr 12, 2018

Last verified

May, 2017

Keywords

  • salivary biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by PeriRx on 2018-04-12.