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

Completed

• Conditions: Oral Squamous Cell Carcinoma
• Interventions: Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

• Registration Number: NCT05049408
• Lead Sponsor: S&T Biomed Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-17
• Primary Completion: 2016-12-07
• Study Completion: 2016-12-07
• Status Verified: 2021-09
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group OPMD	MMP-1 Enzyme Linked Immunosorbent assay (ELISA)	Patients with oral potentially malignant disorders (OPMD)
Group OSCC	MMP-1 Enzyme Linked Immunosorbent assay (ELISA)	Patients with Oral Squamous Cell Carcinoma (OSCC)
Group HC	MMP-1 Enzyme Linked Immunosorbent assay (ELISA)	Healthy Control

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Chi-Mei Medical Center; 🇨🇳 Tainan, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan