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

September 22, 2021 updated by: S&T Biomed Co., Ltd.

Verification of Saliva MMP-1 as a Strong 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwan
        • Chi-Mei Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Randomly selected samples whose donors meeting the eligibility criteria from tissue bank

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group OSCC
Patients with Oral Squamous Cell Carcinoma (OSCC)
Diagnostic test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
Group OPMD
Patients with oral potentially malignant disorders (OPMD)
Diagnostic test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
Group HC
Healthy Control
Diagnostic test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 30 days from initial sample obtained for this study
30 days from initial sample obtained for this study

Secondary Outcome Measures

Outcome 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)
Time Frame: 30 days from initial sample obtained for this study
30 days from initial sample obtained for this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S&T Biomed Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2011

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

December 7, 2016

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STBM-CT-OSCC-DIA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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