Biomarker in Early Diagnosis, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers, Periodontal Diseases
Conditions
Keywords
aMMP-8, matrix, metalloproteinase, cancer, carcinoma, oral, oropharyngeal, mouthrinse
Brief summary
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?
Detailed description
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.
Interventions
None listed
Sponsors
Karolinska Institutet
University of Helsinki
Helsinki University Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test | Within two hours from initial sample obtained for this study | aMMP-8 levels were quantitatively measured in real-time using rapid point-of-care (PoC) chairside kits (Periosafe®, Dentognostics GmbH, Solingen, Germany) and a quantitative reader (Oralyzer®, Dentognostics GmbH, Solingen, Germany) to assess mouth-rinse samples from patients with oral and oropharyngeal cancer in comparison to healthy subjects. The threshold for a positive quantitative aMMP-8 result is set at 20 ng/ml, with readings of ≥20 ng/ml considered positive and those \<19.9 ng/ml considered negative. |
Countries
Finland
Outcome results
None listed