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NCT05049408 Clinical Trial

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

Oral Squamous Cell Carcinoma Clinical Trial

Official title:
Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05049408
Other study ID # STBM-CT-OSCC-DIA001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 17, 2011
Est. completion date December 7, 2016

Study information
Verified date September 2021
Source S&T Biomed Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1160
Est. completion date December 7, 2016
Est. primary completion date December 7, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Chi-Mei Medical Center Tainan

Sponsors (1)
Lead Sponsor Collaborator
S&T Biomed Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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 (Bas — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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