Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer

S&T Biomed Co., Ltd.1,160 enrolled

Overview

The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC.

Study Type

OBSERVATIONAL

Enrollment

1,160

Conditions

Oral Squamous Cell Carcinoma

Interventions

MMP-1 Enzyme Linked Immunosorbent assay (ELISA)DIAGNOSTIC_TEST

The MMP-1 ELISA is to measure salivary MMP-1 levels of participants

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Group OSCC: patients with lesions of OSCC * Group OPMD: patients with lesions of OPMD * Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing Exclusion Criteria: * Subjects having personal history of other cancers or severe diseases

Locations (2)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Chi-Mei Medical Center

Tainan, Taiwan

Outcomes

Primary Outcomes

Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC

Time frame: 30 days from initial sample obtained for this study

Secondary Outcomes

ROC analysis of non-cancer group versus OSCC patients to find the optimal cutoff as the maximum of Youden's index (calculated as sensitivity + specificity - 1 and ranges from 0 to 1, the higher the better)

Time frame: 30 days from initial sample obtained for this study

Data from ClinicalTrials.gov

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