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


N/A
18 Years
N/A
Open (Enrolling)
Both
Oral Squamous Cell Cancer

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Trial Information

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


Inclusion Criteria:



- Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell
cancer

Exclusion Criteria:

- Patients with known prior malignancy or with immune deficiency

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Test specificity over 50% at 90% sensitivity

Outcome Time Frame:

at study completion

Safety Issue:

No

Principal Investigator

Barry Wenig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University

Authority:

United States: Institutional Review Board

Study ID:

PeriRx-1

NCT ID:

NCT01587573

Start Date:

April 2012

Completion Date:

May 2014

Related Keywords:

  • Oral Squamous Cell Cancer
  • salivary biomarkers
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624
Department of Surgery, Michigan Sate University East Lansing, Michigan  48912