Oral Squamous Cell Carcinoma
Conditions
Keywords
Mouth Neoplasms, Head and Neck Neoplasms
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMMP-1 Enzyme Linked Immunosorbent assay (ELISA)
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
Sponsors
S&T Biomed Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC | 30 days from initial sample obtained for this study |
Secondary
| Measure | Time frame |
|---|---|
| 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) | 30 days from initial sample obtained for this study |
Countries
Taiwan
Outcome results
None listed