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

NCT06701058 | Completed

• 1 other identifier: TYH2021220
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

aMMP-8; matrix; metalloproteinase; cancer; carcinoma; oral; oropharyngeal; mouthrinse

Outcome Measures

Primary Outcomes (1)

• aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test

  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

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Karolinska Institutet: collaborator
• University of Helsinki: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Location

Related Publications (34)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Mouth-rinse MMP-8 point-of-care immuno test

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Periodontal Diseases; Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Antti Mäkitie, Prof.

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 22, 2024
• Study Start: March 28, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 18, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)