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CompletedNCT05049408Updated Sep 28, 2021

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

An observational study in Oral Squamous Cell Carcinoma, sponsored by S&T Biomed Co., Ltd.. Completed at 2 sites in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by S&T Biomed Co., Ltd. · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,160
Ages
20 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Oral Squamous Cell Carcinoma

Keywords

  • Mouth Neoplasms
  • Head and Neck Neoplasms
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In context

Mouth Neoplasms

377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.

This study's enrollment of 1,160 is above the median of 90 across 103 observational studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

This is the only study on the registry with S&T Biomed Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Subjects having personal history of other cancers or severe diseases
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,160 participants (actual)
Patient registry
No

Groups and cohorts

  • Group OSCC

    Patients with Oral Squamous Cell Carcinoma (OSCC)

    Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

  • Group OPMD

    Patients with oral potentially malignant disorders (OPMD)

    Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

  • Group HC

    Healthy Control

    Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Interventions

  • Diagnostic testMMP-1 Enzyme Linked Immunosorbent assay (ELISA)

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

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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

2 sites
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, Taiwan
  • Chi-Mei Medical Center
    Tainan, Taiwan
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References and documents

Publications

  • 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. PubMed 32823758 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05049408
Lead sponsor
S&T Biomed Co., Ltd.
Responsible party
Sponsor
First posted
Sep 20, 2021
Start date
Feb 17, 2011
Primary completion
Dec 7, 2016
Completion
Dec 7, 2016
Last update
Sep 28, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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