Oropharyngeal CancersNCT06701058
Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
An observational study of Oropharyngeal Cancers and Biomarker in Early Diagnosis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Cancers, Biomarker in Early Diagnosis, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 107 participants
- Where
- 1 siteFinland
- Study dates
- 28 Mar 2022to 18 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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
- 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
- Medical subject headings
- Oropharyngeal Neoplasms, Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck, Periodontal Diseases, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within two hours from initial sample obtained for this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start28 Mar 2022
- Primary completion1 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal CancersStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Helsinki
- Responsible party
- Principal investigator, Sebastian Ahlstrand, Helsinki University Central Hospital
- Investigators
- Antti Mäkitie, Prof., Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701058
- Sponsor's protocol ID
- TYH2021220
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36900047Moilanen 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.
PubMed 12081207Guarnieri 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.
PubMed 35055373Tchetverikov 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.
PubMed 15194590Weiss SJ. Tissue destruction by neutrophils. N Engl J Med. 1989 Feb 9;320(6):365-76. doi: 10.1056/NEJM198902093200606. No abstract available.
PubMed 2536474Feng 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.
PubMed 30602733Deng 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.
PubMed 33998040Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
PubMed 26511519Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
PubMed 28094848Preshaw PM, Hefti AF, Jepsen S, Etienne D, Walker C, Bradshaw MH. Subantimicrobial dose doxycycline as adjunctive treatment for periodontitis. A review. J Clin Periodontol. 2004 Sep;31(9):697-707. doi: 10.1111/j.1600-051X.2004.00558.x.
PubMed 15312090Maruyama Y, Nishimoto Y, Umezawa K, Kawamata R, Ichiba Y, Tsutsumi K, Kimura M, Murakami S, Kakizawa Y, Kumagai T, Yamada T, Fukuda S. Comparison of oral metabolome profiles of stimulated saliva, unstimulated saliva, and mouth-rinsed water. Sci Rep. 2022 Jan 13;12(1):689. doi: 10.1038/s41598-021-04612-x.
PubMed 35027617Drouin L, Overall CM, Sodek J. Identification of matrix metalloendoproteinase inhibitor (TIMP) in human parotid and submandibular saliva: partial purification and characterization. J Periodontal Res. 1988 Nov;23(6):370-7. doi: 10.1111/j.1600-0765.1988.tb01615.x. No abstract available.
PubMed 2851041Hsiao YC, Chi LM, Chien KY, Chiang WF, Chen SF, Chuang YN, Lin SY, Wu CC, Chang YT, Chu LJ, Chen YT, Chia SL, Chien CY, Chang KP, Chang YS, Yu JS. Development of a Multiplexed Assay for Oral Cancer Candidate Biomarkers Using Peptide Immunoaffinity Enrichment and Targeted Mass Spectrometry. Mol Cell Proteomics. 2017 Oct;16(10):1829-1849. doi: 10.1074/mcp.RA117.000147. Epub 2017 Aug 18.
PubMed 28821604Monea M, Pop AM. The Use of Salivary Levels of Matrix Metalloproteinases as an Adjuvant Method in the Early Diagnosis of Oral Squamous Cell Carcinoma: A Narrative Literature Review. Curr Issues Mol Biol. 2022 Dec 12;44(12):6306-6322. doi: 10.3390/cimb44120430.
PubMed 36547091Sorsa T, Nwhator SO, Sakellari D, Grigoriadis A, Umeizudike KA, Brandt E, Keskin M, Tervahartiala T, Parnanen P, Gupta S, Mohindra R, Bostanci N, Buduneli N, Raisanen IT. aMMP-8 Oral Fluid PoC Test in Relation to Oral and Systemic Diseases. Front Oral Health. 2022 Jun 10;3:897115. doi: 10.3389/froh.2022.897115. eCollection 2022.
PubMed 35757444
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT06701058
- Acronym / sponsor ID
- TYH2021220
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Helsinki
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 36900047Keskin 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.
- Background: PubMed 12081207Moilanen 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.
- Background: PubMed 35055373Guarnieri 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.
- Background: PubMed 15194590Tchetverikov 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.
- Background: PubMed 2536474Weiss SJ. Tissue destruction by neutrophils. N Engl J Med. 1989 Feb 9;320(6):365-76. doi: 10.1056/NEJM198902093200606. No abstract available.
- Background: PubMed 30602733Feng 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.
- Background: PubMed 33998040Deng 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.
- Background: PubMed 26511519Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
- Background: PubMed 28094848Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
- Background: PubMed 15312090Preshaw PM, Hefti AF, Jepsen S, Etienne D, Walker C, Bradshaw MH. Subantimicrobial dose doxycycline as adjunctive treatment for periodontitis. A review. J Clin Periodontol. 2004 Sep;31(9):697-707. doi: 10.1111/j.1600-051X.2004.00558.x.
- Background: PubMed 35027617Maruyama Y, Nishimoto Y, Umezawa K, Kawamata R, Ichiba Y, Tsutsumi K, Kimura M, Murakami S, Kakizawa Y, Kumagai T, Yamada T, Fukuda S. Comparison of oral metabolome profiles of stimulated saliva, unstimulated saliva, and mouth-rinsed water. Sci Rep. 2022 Jan 13;12(1):689. doi: 10.1038/s41598-021-04612-x.
- Background: PubMed 2851041Drouin L, Overall CM, Sodek J. Identification of matrix metalloendoproteinase inhibitor (TIMP) in human parotid and submandibular saliva: partial purification and characterization. J Periodontal Res. 1988 Nov;23(6):370-7. doi: 10.1111/j.1600-0765.1988.tb01615.x. No abstract available.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti Mäkitie, Prof. study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Cancers and Biomarker in Early Diagnosis, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701058, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.