Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
aMMP-8 levels and status in mouth rinse-samples measured utilizing aMMP-8 Point-of-Care Test
时间窗: 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.
次要结局
未报告次要终点
研究者
Sebastian Ahlstrand
Principal Investigator
Helsinki University Central Hospital