Non-invasive Oral Cancer Screening Among Individuals Who Have HIV Infection
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL)
研究概览
简要总结
The goal of this clinical research study is to learn how a new method for performing oral (mouth) exams can help doctors check for suspicious lesions (called premalignant and malignant oral lesions [PMOL]) in the mouth of HIV-infected smokers.
详细描述
If you agree to take part in this study, you will be asked to come to the clinic for 2 study visits.
First Study Visit:
- You will be asked questions about your history of tobacco, alcohol, and mouthwash use. You will also be asked questions about your demographic information (such as age, sex at birth, sexual orientation and gender identification, educational level, and insurance status). This interview will last about 7 minutes.
- You will be asked to blow into a device that measures the amount of carbon monoxide in your lungs. Smokers may have a larger amount of carbon monoxide in their lungs.
- You will be given referral information for a tobacco cessation program if you want help to stop smoking.
After this first interview, you will have a standard dental exam of your mouth and throat using normal office lighting. Any suspected PMOLs will be photographed. Right after that, a second dental exam will be performed, using a hand-held fluorescent light device. This device will be shined into your mouth to help the doctor check for PMOLs. Any suspected PMOLs will be photographed under the fluorescent light.
Second Study Visit (Follow-up):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services
- •Being able to speak English and/or Spanish
排除标准
- •patients under 18 years of age
- •patients current participation in a tobacco cessation program
- •Patients unwilling or unable to provide consent
- •Patients declining oral biopsies
结局指标
主要结局
Positive Predictive Value for Premalignant and Malignant oral lesions (PMOL)
时间窗: 2 weeks
Positive predictive value defined as the number of true positives (confirmed PMOLs) divided by the total number of suspicious lesions.
次要结局
未报告次要终点