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

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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Key information

Conditions

Oral Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Diagnostic Test

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

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

Sponsors and collaborators

Lead sponsor

S&T Biomed Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Sep 20, 2021
Registry last updated: Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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