Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Biomarker in Early Diagnosis; Periodontal Diseases; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Oropharyngeal Cancers

Study type: Observational

Funder types: Other

Identifiers

NCT06701058

TYH2021220

Details and patient eligibility

About

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?

Full 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.

Enrollment: 107 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

107 participants in 2 patient groups

Cancer patients

Description:

Oral and oropharyngeal cancer patients

Control patients

Description:

Control participants with no history of any type of cancer cancer in the past five years