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

NCT ID: NCT05049408

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-17

Study Completion Date

2016-12-07

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group OSCC

Patients with Oral Squamous Cell Carcinoma (OSCC)

MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

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

Group OPMD

Patients with oral potentially malignant disorders (OPMD)

MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

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

Group HC

Healthy Control

MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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S&T Biomed Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Chi-Mei Medical Center

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 32823758 (View on PubMed)

Other Identifiers

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STBM-CT-OSCC-DIA001

Identifier Type: -

Identifier Source: org_study_id

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