Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
NCT ID: NCT06701058
Last Updated: 2024-11-22
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
107 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-03-28
Study Completion Date
2024-09-18
Brief Summary
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The goal of this observational study is to evaluate whether the active-matrix metalloproteinase-8 (aMMP-8) mouth-rinse test can help detect oral and oropharyngeal cancers. Researchers measured aMMP-8 levels in mouth-rinse samples collected from 77 cancer participants and 50 non-cancer participants in a clinical setting.
The main question this study seeks to answer:
Can the aMMP-8 mouth-rinse test accurately identify and differentiate cancer participants from non-cancer participants in real-time?
The main question this study seeks to answer:
Can the aMMP-8 mouth-rinse test accurately identify and differentiate cancer participants from non-cancer participants in real-time?
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Detailed Description
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The goal of this prospective study is to evaluate whether the active-matrix metalloproteinase-8 (aMMP-8) mouth-rinse test can detect and differentiate 72 oral and oropharyngeal cancers from 50 control participants.
In sampling process patients were asked to pre-rinse with tap water for 30 s. After one-minute wait, they were asked to rinse their mouth 30 s with 5 mL of distilled water provided in the test kit and to spit it out in a sterile measuring cup.
The sample solution were poured into the opening of the test cassette placed on the test system (ORALyzer®) for quantitative results. After obtaining the quantitative results in 5-6 min, the cassette was promptly removed to conduct the qualitative evaluation (Periosafe®).
The expression of aMMP-8 was compared with various factors, including age, sex, smoking status, periodontitis, tumor size, nodal or distal metastases, cancer stage, histological grade, and tumor site. Statistical analysis was performed to evaluate these relationships.
In sampling process patients were asked to pre-rinse with tap water for 30 s. After one-minute wait, they were asked to rinse their mouth 30 s with 5 mL of distilled water provided in the test kit and to spit it out in a sterile measuring cup.
The sample solution were poured into the opening of the test cassette placed on the test system (ORALyzer®) for quantitative results. After obtaining the quantitative results in 5-6 min, the cassette was promptly removed to conduct the qualitative evaluation (Periosafe®).
The expression of aMMP-8 was compared with various factors, including age, sex, smoking status, periodontitis, tumor size, nodal or distal metastases, cancer stage, histological grade, and tumor site. Statistical analysis was performed to evaluate these relationships.
Conditions
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Oropharyngeal Cancers
Biomarker in Early Diagnosis
Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
Periodontal Diseases
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Cancer patients
Oral and oropharyngeal cancer patients
No interventions assigned to this group
Control patients
Control participants with no history of any type of cancer cancer in the past five years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Biopsy-confirmed oral or oropharyngeal cancer identified by the following International Classification of Diseases (ICD-10) codes: C00-C06, C08-C10, C13, and C32 according to the American Joint Committee on Cancer (AJCC) 8th Edition
* Adult
* Adult
Exclusion Criteria
* In-situ cancer
* Previous cancer diagnosis within five years prior to the examination
* Use of tetracyclines at the time of sampling
* Did not follow the manufacturer's instructions prior to the mouth-rinse sample (i.e. brushing teeth before sampling)
* Previous cancer diagnosis within five years prior to the examination
* Use of tetracyclines at the time of sampling
* Did not follow the manufacturer's instructions prior to the mouth-rinse sample (i.e. brushing teeth before sampling)
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Karolinska Institutet
OTHER
Sponsor Role
collaborator
University of Helsinki
OTHER
Sponsor Role
collaborator
Helsinki University Central Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Sebastian Ahlstrand
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Antti Mäkitie, Prof.
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Site Status
Countries
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Finland
References
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Other Identifiers
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TYH2021220
Identifier Type: -
Identifier Source: org_study_id
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