Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-04 @ 9:45 AM
Study NCT ID:
NCT06701058
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
Sponsor:
Helsinki University Central Hospital
Organization:
Study Overview
Official Title:
Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: