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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group OSCC | Patients with Oral Squamous Cell Carcinoma (OSCC) |
| |
| Group OPMD | Patients with oral potentially malignant disorders (OPMD) |
| |
| Group HC | Healthy Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMP-1 Enzyme Linked Immunosorbent assay (ELISA) | Diagnostic Test | The MMP-1 ELISA is to measure salivary MMP-1 levels of participants |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Randomly selected samples whose donors meeting the eligibility criteria from tissue bank
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Chi-Mei Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32823758 | Result | Chang YT, Chu LJ, Liu YC, Chen CJ, Wu SF, Chen CH, Chang IY, Wang JS, Wu TY, Dash S, Chiang WF, Chiu SF, Gou SB, Chien CY, Chang KP, Yu JS. Verification of Saliva Matrix Metalloproteinase-1 as a Strong Diagnostic Marker of Oral Cavity Cancer. Cancers (Basel). 2020 Aug 13;12(8):2273. doi: 10.3390/cancers12082273. |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Tainan |
| Taiwan |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |