NCT06701058|Completed
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Sponsor study identifier
observational
107
1 country
1
Study Start
March 28, 2022
Actual (reported)Primary Completion
September 1, 2024
Actual (reported)Study Completion
September 18, 2024
Actual (reported)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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 18, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2022
Actual (reported)September 1, 2024
Actual (reported)September 18, 2024
Actual (reported)November 6, 2024
Actual (reported)November 22, 2024
Actual (reported)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
Oral and oropharyngeal cancer patients
Control participants with no history of any type of cancer cancer in the past five years
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
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Keskin M, Rintamarttunen J, Gulcicek E, Raisanen IT, Gupta S, Tervahartiala T, Patila T, Sorsa T. A Comparative Analysis of Treatment-Related Changes in the Diagnostic Biomarker Active Metalloproteinase-8 Levels in Patients with Periodontitis. Diagnostics (Basel). 2023 Feb 27;13(5):903. doi: 10.3390/diagnostics13050903.
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Mouth-rinse MMP-8 point-of-care immuno test
Antti Mäkitie, Prof.
Helsinki University Central Hospital
107 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2024
First Posted
November 22, 2024
Study Start
March 28, 2022
Actual (reported)Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease
Contact the study team to confirm eligibility.
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Primary Completion
September 1, 2024
Actual (reported)Study Completion
September 18, 2024
Actual (reported)Last Updated
November 22, 2024
Record last verified: 2024-11
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.
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