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

November 21, 2024 updated by: Sebastian Ahlstrand, Helsinki University Central Hospital

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?

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study included participants of all ages and genders. All patients were eligible regardless of other medical conditions, except for those with a history of cancer within five years prior to sampling. Cancer patients were selected from a multidisciplinary meeting, and suitable patients were contacted to assess their willingness to participate. Control participants were recruited from the otorhinolaryngology outpatient clinic, where they were being studied and/or treated for other otorhinolaryngology-related conditions

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cancer patients
Oral and oropharyngeal cancer patients
Control patients
Control participants with no history of any type of cancer cancer in the past five years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test
Time Frame: 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.
Within two hours from initial sample obtained for this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Karolinska Institutet
University of Helsinki

Investigators

  • Study Director: Antti Mäkitie, Prof., Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 18, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYH2021220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data presented in this study are available on request from the corresponding author. The data are not publicly available due to patient data confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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