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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by PeriRx
Information provided by (Responsible Party):
PeriRx Identifier:
First received: April 26, 2012
Last updated: September 28, 2014
Last verified: September 2014
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.

Condition Intervention
Oral Squamous Cell Carcinoma
Other: saliva collection prior to clinically driven oral biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by PeriRx:

Primary Outcome Measures:
  • Test specificity at 90% sensitivity [ Time Frame: at study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validation of individual mRNA and protein markers [ Time Frame: After enrollment of 30 patients with cancer ] [ Designated as safety issue: No ]
  • Validation of a pre-specified multi marker model [ Time Frame: After enrollment of 30 patients with cancer ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
cell free saliva

Estimated Enrollment: 370
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
oral lesions
oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy
Other: saliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with oral lesions suspicious for squamous cell cancer and scheduled for clinically driven biopsy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01587573

United States, Illinois
University of Illinois at Chicago Withdrawn
Chicago, Illinois, United States, 60612
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Joseph I Helman, DMD    734-763-5963   
Contact: Mark Vartanian, BA    7347636954   
Principal Investigator: Joseph I Helman, DMD         
Department of Surgery, Michigan Sate University Terminated
East Lansing, Michigan, United States, 48912
St. John Providence Health System Recruiting
Warren, Michigan, United States, 48092
Contact: Michael Shaw, PhD    248-967-7791   
Principal Investigator: Harvey Zalesin, DDS         
Sponsors and Collaborators
Principal Investigator: Barry Wenig, MD University of Illinois at Chicago
Study Chair: Joseph I Helman, DMD University Michigan
  More Information

No publications provided

Responsible Party: PeriRx Identifier: NCT01587573     History of Changes
Other Study ID Numbers: PeriRx-1
Study First Received: April 26, 2012
Last Updated: September 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by PeriRx:
salivary biomarkers

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell processed this record on December 01, 2015