Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer
1 other identifier
observational
1,160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2016
CompletedFirst Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedSeptember 28, 2021
September 1, 2021
5.8 years
September 10, 2021
September 22, 2021
Conditions
Keywords
Outcome Measures
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
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)
30 days from initial sample obtained for this study
Study Arms (3)
Group OSCC
Patients with Oral Squamous Cell Carcinoma (OSCC)
Group OPMD
Patients with oral potentially malignant disorders (OPMD)
Group HC
Healthy Control
Interventions
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
Eligibility Criteria
Randomly selected samples whose donors meeting the eligibility criteria from tissue bank
You may qualify if:
- 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
You may not qualify if:
- Subjects having personal history of other cancers or severe diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Chi-Mei Medical Center
Tainan, Taiwan
Related Publications (1)
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.
PMID: 32823758RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2021
First Posted
September 20, 2021
Study Start
February 17, 2011
Primary Completion
December 7, 2016
Study Completion
December 7, 2016
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share