Oral Squamous Cell CarcinomaNCT05049408
Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer
An observational study of Oral Squamous Cell Carcinoma, run by S&T Biomed Co., Ltd. at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,160 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Feb 2011to 7 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Randomly selected samples whose donors meeting the eligibility criteria from tissue bank
Who may be able to join
- 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
Who cannot join
- Subjects having personal history of other cancers or severe diseases
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Chi-Mei Medical Center
Tainan
About this study
Official title: 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.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- MMP-1 Enzyme Linked Immunosorbent assay (ELISA)
- Keywords
- Mouth Neoplasms, Head and Neck Neoplasms
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMP-1 Enzyme Linked Immunosorbent assay (ELISA)Diagnostic test
The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
| Study group | Role | What they receive |
|---|---|---|
| Group OSCC | Patients with Oral Squamous Cell Carcinoma (OSCC) Receives: Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA) | |
| Group OPMD | Patients with oral potentially malignant disorders (OPMD) Receives: Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA) | |
| Group HC | Healthy Control Receives: Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC
Measured: 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)
Measured: 30 days from initial sample obtained for this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start17 Feb 2011
- Primary completion7 Dec 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- S&T Biomed Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049408
- Sponsor's protocol ID
- STBM-CT-OSCC-DIA001
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer
- ClinicalTrials.gov ID
- NCT05049408
- Acronym / sponsor ID
- STBM-CT-OSCC-DIA001
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Mouth Neoplasms, Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- S&T Biomed Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2011 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group OSCC | – | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)Patients with Oral Squamous Cell Carcinoma (OSCC) |
| Group OPMD | – | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)Patients with oral potentially malignant disorders (OPMD) |
| Group HC | – | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)Healthy Control |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Randomly selected samples whose donors meeting the eligibility criteria from tissue bank
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects having personal history of other cancers or severe diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMP-1 Enzyme Linked Immunosorbent assay (ELISA)The MMP-1 ELISA is to measure salivary MMP-1 levels of participants | Diagnostic test | Group HC, Group OPMD, Group OSCC |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Results publication: PubMed 32823758Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma, run by S&T Biomed Co., Ltd. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.