Repurposing Transnasal Esophagoscopy: Targeting Interventions for a Community That Has Been Targeted for Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Develop risk/screening criteria for esophageal squamous cell carcinoma in at risk populations
研究概览
简要总结
This research study is being done for 2 reasons: 1) The investigators want to learn about the eating, smoking and drinking habits of adults, 18 years of age and older, in various Chicago communities, and 2) the investigators want to offer screening for participants whose smoking and drinking habits put them at risk for cancer.
详细描述
There are longstanding disparities in healthcare outcomes in the United States. These differences often correlate from the effects of structural racism and how this factor has shaped healthcare in our society.
Esophageal cancer presents as one of two distinct histological cell types, adenocarcinoma and squamous cell carcinoma (SCC). The majority of White patients presenting with esophageal cancer are diagnosed with adenocarcinoma while Black and non-caucasian patients are more commonly diagnosed with squamous cell carcinoma. The detection and treatment of these two types of esophageal cancers vary.
Trans-nasal esophagoscopy (TNE) is used primarily to assess chronic acid reflux as well as Barrett's esophagus, both symptoms being associated with adenocarcinoma. The use of TNE for disease screening offers the opportunity for early diagnosis and treatment of esophageal adenocarcinoma. Currently there is no parallel method of screening and diagnosis for patients with the potential for squamous cell carcinoma (SCC).
In an effort to decrease the disease identification, diagnosis, and treatment gap between these populations, this study will evaluate the use of TNE as a screening tool for African-Americans and non-caucasian patients with high risk factors associated with the development of esophageal SCC.
All adult patients 18 years of age and older will be asked to participate in a survey at one of the UI Health community health centers. The survey will include questions about smoking and alcohol consumption habits, which have been shown to be specific risk factors associated with esophageal SCC. Additional information, such as the use of mentholated cigarettes and fortified wines will be surveyed as such products are selectively marketed in African American communities and may increase the prevalence of SCC in these communities. Following review of the survey results from the health centers, all patients presenting with a dysphasia or difficulty swallowing, and patients who are 40 years of age and older and who have been determined to be high risk for SCC based on their survey results, will be offered the opportunity to have a TNE screening for esophageal cancer. Data gathered as a result of the study will be shared with participating communities and with medical health providers in an effort to improve patient knowledge and access to quality healthcare.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Male and female patients 18 years of age or older
- •Patients being seen at one of the UI Health Centers for an ear, nose, or throat related concern.
- •Patients who have a history of both smoking and drinking.
- •Patients must be willing to complete a study survey.
- •Patients must understand the purpose and procedures of the study and be willing to participate.
- •Patients who speak English.
- •All adult men and women who meet the study criteria will be asked to participate in the study without regard to race, gender or socioeconomic status.
- •For Part 2 of the study, inclusion criteria includes all patients 40 and over with a history or smoking and drinking as well as patients 18 years of age and older who present with dysphasia and/or pain when swallowing. Patients eligible for Part 2 of the study will be informed of the study, but they will not be consented during their clinic visit.
排除标准
- •Male and Female patients under the age of
- •Patients who are not being seen at one of the UI Health Community Health
- •Centers for an ear, nose or throat related concern.
- •Patients who do not have a history of both drinking and smoking.
- •Patients unwilling to complete the study survey.
- •Women who are pregnant will be excluded from both Part 1 and Part 2 of the study.
- •Patients unable to understand the purpose and procedures of the study and/or who are not willing to participate.
- •Patients who do not speak English.
- •Excluded or Vulnerable Populations
- •Minors will be excluded from the study because they are not at risk for the factors being studied in the research.
- •Subjects who are not English speaking will be excluded due to the limited capacity of the primary investigators to obtain informed consent in this population.
结局指标
主要结局
Develop risk/screening criteria for esophageal squamous cell carcinoma in at risk populations
时间窗: Through study completion, anticipating 2 years
The researchers hope our data will serve to help create a risk stratification that can parallel current guidelines for screening patients for adenocarcinoma (which primarily affects Caucasian males). The researchers will compare results of trans-nasal esophagoscopy (TNE) exam and any biopsy specimens collected with the risk profile generated by survey results.
community education
时间窗: Ongoing throughout the study, approximately 2 years
The design of this study includes partnership with the at-risk community to engage in education about the stated risk factors and promote preventive health and encourage participation in screenings.
Conduct a population survey of UI Health and Mile Square Community Center patients focusing on specific risk factors associated with esophageal squamous cell carcinoma (ESCC)
时间窗: Through study completion, an average of 2 years
The researchers will collect data on the consumption of alcohol and tobacco as they are known risk factors for ESCC. The researchers will specifically assess consumption of fortified wines and mentholated cigarettes based on the targeted marketing of these products in identified communities. The researchers will also assess consumption of fresh fruits and vegetables and proportion of fat in dietary consumption to assess whether these conditions are associated with cancer risk.
次要结局
未报告次要终点
研究者
H Steven Sims
Francis L. Lederer Professor, Otolaryngology - Head and Neck Surgery Director, The Chicago Institute for Voice Care (CIVC)
University of Illinois at Chicago