LCCC 1608 - HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Risk factors for ESCC - HIV Infection
研究概览
简要总结
The primary purpose of this single-center, case-control, non-interventional study is to determine risk factors which contribute to the development of esophageal squamous cell carcinoma (ESCC) at Kamuzu Central Hospital (KCH) and St. Gabriel Hospital (SGH) in Malawi.
详细描述
RATIONALE FOR RESEARCH
The Rift Valley of Africa is a 'hot spot' for ESCC, yet little is known about the etiology of this disease in Sub-Saharan Africa. In Malawi, ESCC is the third commonest cancer nationwide behind Kaposi sarcoma and cervical carcinoma. Among cancers that are not classically HIV-related, ESCC has the highest incidence in Malawi. The ESCC burden recorded in the national cancer registry is also likely an underestimate, as many cases may go undiagnosed and unregistered. Additionally, few data are available on the epidemiology of ESCC in Malawi, and underlying reasons for high frequency of the disease are largely unknown. This knowledge gap is a major barrier to public health prevention efforts. Given that survival after ESCC diagnosis is dismal in Malawi (12% at 1 year), developing evidence-based prevention efforts is paramount.
The proposed study will make a significant contribution to existing literature from Malawi and Sub-Saharan Africa in several important respects. First, previous epidemiologic studies of ESCC in Malawi have been limited by challenges with appropriate control selection, which may have limited the validity of their findings. Secondly, our study will include prospective clinical follow-up of confirmed ESCC cases as they receive treatment under local conditions to provide accurate survival estimates. Thirdly, biospecimens from consenting patients will permit etiology and pathogenesis studies to understand mechanisms of ESCC development, which can be correlated with high-quality clinical and epidemiologic data. Finally, we plan to coordinate with other ESCC researchers in eastern and southern Africa to harmonize data collection, and help create a regional consortium in which Malawi can be a founding member and active participant.
Primary Objective: Identify demographic and environmental risk factors for ESCC through a case-control study implemented at KCH and SGH. Hypothesis: Modifiable risk factors contribute significantly to ESCC. These include polycyclic aromatic hydrocarbon (PAH) exposure from various sources, excessively hot beverages, dietary factors such as maize fumonisin and low selenium, and HIV infection.
Secondary Objective: Identify common genetic and epigenetic alterations in germline and somatic DNA associated with ESCC development. Hypothesis: Recurring genetic and epigenetic alterations can facilitate risk stratification, development of early detection biomarkers, and identification of novel treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Cases Inclusion Criteria
- •All patients > 18 years of age diagnosed with histologically confirmed ESCC are eligible to be a case regardless of sex or place of residence.
- •Diagnosis of ESCC (histologically confirmed)
- •Subject able to understand and provide written consent in English or Chichewa
- •Able to understand and comply with study procedures for the entire length of the study
- •Controls Inclusion Criteria
- •All patients > 18 years of age without a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are eligible to be controls, regardless of age, sex, or place of residence
- •Subject able to understand and provide written consent in English or Chichewa
- •Able to understand and comply with study procedures for the entire length of the study
排除标准
- •Cases Exclusion Criteria
- •Healthcare provider determines it is unsafe to perform a biopsy
- •Mental impairment which precludes provision of informed consent
- •Patients who are unable to provide their past medical history
- •Controls Exclusion Criteria
- •All patients > 18 years of age with a history of esophageal cancer or esophageal squamous dysplasia, a history of other cancer, or upper gastrointestinal diseases are ineligible to be controls
- •Patients with significant difficulty swallowing
- •Mental impairment which precludes provision of informed consent
- •Patients who are unable to provide their past medical history
结局指标
主要结局
Risk factors for ESCC - HIV Infection
时间窗: 2 years
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: HIV infection
Risk factors for ESCC - PAH exposure
时间窗: 2 years
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: PAH exposure
Risk factors for ESCC - Tobacco and alcohol consumption
时间窗: 2 years
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Tobacco and alcohol consumption
Risk factors for ESCC - Scalding hot beverages and foods,
时间窗: 2 years
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Scalding hot beverages and foods
Survival estimates after ESCC diagnosis in Malawi.
时间窗: 2 years
To assess survival after ESCC diagnosis in Malawi.
Risk factors for ESCC - Dietary factors including fumonisin and selenium
时间窗: 2 years
To identify risk factors for ESCC through a case-control study implemented at a national teaching hospital, specifically focused on the following exposures: Dietary factors including fumonisin and selenium
次要结局
- The common somatic genetic and epigenetic alterations in ESCC tumors from Malawi.(2 years)
- The germline genetic and epigenetic alterations associated with susceptibility to ESCC.(2 years)