Esophageal Squamous Cell Carcinoma African Prevention Research (ESCCAPE) Cytosponge™ Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Prevalence of any-grade of esophageal dysplasia
研究概览
简要总结
A Tanzanian pilot study to test the feasibility of using the Cytosponge™ device - a less-invasive endoscopy alternative - for research on esophageal squamous cell carcinoma in African settings.
详细描述
The Cytosponge™ consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed with the use of water and allowed to reach the stomach while remaining attached to the suture which is held onto by the patient or nurse (and which is affixed to a card preventing inadvertent swallowing of the suture). In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus. After retrieval the Cytosponge™ containing the cytological specimen placed in preservative fluid. The typical cell yield of the procedure is 250,000. These cells are used to prepare a clot which is fixed with formalin and embedded in paraffin for sectioning and slide preparation. Slides are then examined under a microscope for pathological diagnosis and characterisation. This device was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008 and is a Class 1 device according to European Medical Devices 93/42/EEC as implemented in the United Kingdom by The Medical Devices Regulations 2002 (SI No 618).
Healthy adult (>30 years) volunteers will be recruited during routine visits to the Majengo Healthcare Centre in Moshi, Tanzania where they will be informed of the study and invited to participate. Their participation will then involve the following:
- Completing a short lifestyle questionnaire.
- Swallowing the Cytosponge™ device to collect cells from their oesophagus.
- Being contacted by telephone 7-days post procedure to assess acceptability.
The following endpoints will be investigated:
Core:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 years or older.
- •Resident of Kilimanjaro Region for 10 years or more.
排除标准
- •Eaten or drank within the last 4 hours.
- •Known current pregnancy.
- •Objection to CytoSCCAPE data collection.
- •Symptoms of dysphagia (difficulty swallowing).
- •Recorded history of oropharyngeal, esophageal or gastric cancer
- •Received prior surgical intervention to the esophagus.
- •Esophageal varices, stricture or requiring esophageal dilation.
- •Recorded cirrhosis of the liver.
- •Swallowing difficulty due to cerebrovascular accident or neurological disorder.
- •Recent history of vomiting blood.
- •Recent use of anticoagulation therapy/medication.
- •Myocardial infarction or any cardiac event within the last 6 months.
- •Lacking capacity to provide informed consent.
- •Unwilling to swallow beef gelatine capsule due to dietary preferences.
结局指标
主要结局
Prevalence of any-grade of esophageal dysplasia
时间窗: 6 months
Any grade (low, moderate or high) of dysplasia. The Three-tier grading scheme will be used: grade 1 (low) well-differentiated; grade 2 (intermediate) for moderately differentiated; grade 3 (high) for poorly differentiated.
Distribution of acceptability scores
时间窗: After cytosponge swallow
Device satisfaction rating assessed on a visual analogue scale from 1 to 10, representing the best and worst satisfaction levels, respectively, and a cartoon face was used to assist interpretation of this scale.
次要结局
- Prevalence of other benign esophageal pathologies(6 months)