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

• Sponsor: S&T Biomed Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05049408
• Collaborator: (none)
• Enrollment: 1,160
• Locations: 2
• Actual Duration (Months): 69.7
• Patients Per Site: 580
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Squamous Cell Carcinoma	Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)

Study Design

• Study Type: Observational
• Actual Enrollment: 1160 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer
• Actual Study Start Date: Feb 17, 2011
• Actual Primary Completion Date: Dec 7, 2016
• Actual Study Completion Date: Dec 7, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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 [30 days from initial sample obtained for this study]

Secondary Outcome Measures

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) [30 days from initial sample obtained for this study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan
2	Chi-Mei Medical Center	Tainan		Taiwan

Sponsors and Collaborators

• S&T Biomed Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S&T Biomed Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05049408
• Other Study ID Numbers: STBM-CT-OSCC-DIA001
• First Posted: Sep 20, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by S&T Biomed Co., Ltd.: Mouth Neoplasms; Head and Neck Neoplasms
• Additional relevant MeSH terms: Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Sep 28, 2021