Trials / Completed

CompletedNCT06701058

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 107 (actual)

Sponsor: Helsinki University Central Hospital · Academic / Other
Sex: All
Age: —
Healthy volunteers: Accepted

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.

Conditions

Timeline

Start date: 2022-03-28
Primary completion: 2024-09-01
Completion: 2024-09-18
First posted: 2024-11-22
Last updated: 2024-11-22

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT06701058. Inclusion in this directory is not an endorsement.