Clinical trial · Observational
Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
NCT06701058CI-TRIAL-00082920completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biomarker in Early Diagnosis | — | UNRESOLVED | — |
| Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharyngeal Cancers | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Periodontal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cancer patients
- description
- Oral and oropharyngeal cancer patients
- label
- Control patients
- description
- Control participants with no history of any type of cancer cancer in the past five years
Primary outcomes (1)
- measure
- aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test
- timeFrame
- Within two hours from initial sample obtained for this study
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (34)
- BACKGROUNDKeskin 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. PMID 36900047
- BACKGROUNDMoilanen M, Pirila E, Grenman R, Sorsa T, Salo T. Expression and regulation of collagenase-2 (MMP-8) in head and neck squamous cell carcinomas. J Pathol. 2002 May;197(1):72-81. doi: 10.1002/path.1078. PMID 12081207
- BACKGROUNDGuarnieri R, Zanza A, D'Angelo M, Di Nardo D, Del Giudice A, Mazzoni A, Reda R, Testarelli L. Correlation between Peri-Implant Marginal Bone Loss Progression and Peri-Implant Sulcular Fluid Levels of Metalloproteinase-8. J Pers Med. 2022 Jan 6;12(1):58. doi: 10.3390/jpm12010058. PMID 35055373
- BACKGROUNDTchetverikov I, Ronday HK, Van El B, Kiers GH, Verzijl N, TeKoppele JM, Huizinga TW, DeGroot J, Hanemaaijer R. MMP profile in paired serum and synovial fluid samples of patients with rheumatoid arthritis. Ann Rheum Dis. 2004 Jul;63(7):881-3. doi: 10.1136/ard.2003.013243. PMID 15194590
- BACKGROUNDWeiss SJ. Tissue destruction by neutrophils. N Engl J Med. 1989 Feb 9;320(6):365-76. doi: 10.1056/NEJM198902093200606. No abstract available. PMID 2536474
- BACKGROUNDFeng Y, Li Q, Chen J, Yi P, Xu X, Fan Y, Cui B, Yu Y, Li X, Du Y, Chen Q, Zhang L, Jiang J, Zhou X, Zhang P. Salivary protease spectrum biomarkers of oral cancer. Int J Oral Sci. 2019 Jan 3;11(1):7. doi: 10.1038/s41368-018-0032-z. PMID 30602733
- BACKGROUNDDeng K, Pelekos G, Jin L, Tonetti MS. Diagnostic accuracy of a point-of-care aMMP-8 test in the discrimination of periodontal health and disease. J Clin Periodontol. 2021 Aug;48(8):1051-1065. doi: 10.1111/jcpe.13485. Epub 2021 Jun 10.