Surveillance and Early Detection of Esophageal Squamous Cell Carcinoma With Minimally-invasive Cytosponge™ Cell Collection Device Coupled With Molecular Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
研究概览
简要总结
Surveillance and early detection of esophageal squamous cell carcinoma with minimally-invasive Cytosponge™ cell collection device coupled with molecular biomarkers.
详细描述
The goal of the study is to identify molecular abnormalities at each developmental stage of esophageal squamous cell carcinoma (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and early squamous cell carcinoma) in order to establish new molecular biomarkers with potential for early detection and surveillance of the disease using the minimally-invasive Cytosponge™ cell collection device. Firstly, tissue samples after endoscopic treatment (endoscopic mucosal resection and endoscopic submucosal dissection) for squamous intraepithelial neoplasia and early squamous cell carcinoma will be analyzed with the use of the next-generation sequencing to identify potential diagnostic biomarkers. Afterward, patients with- and at risk- of esophageal squamous cell carcinoma will be recruited to undergo a diagnostic endoscopy with biopsies (the gold standard) and Cytosponge procedure. The diagnostic accuracy of Cytosponge coupled with molecular biomarkers will be evaluated to compare with the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with esophageal squamous cell cancer (ESCC):
- •Patients ≥18 years of with adequate performance status for endoscopy
- •Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
- •Patients currently undergoing oncological treatment (Rth/Chth)
- •Consent to provide tissue samples for the study
- •Dysphagia grade ≤2 (able to swallow mixed foods and tablets)
- •Patients at high risk for ESCC:
- •Patients ≥18 years of age with adequate performance status for endoscopy
- •Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)
- •Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)
- •Consent to provide tissue samples for the study
- •Dysphagia grade ≤2
排除标准
- •(for both groups of patients):
- •Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
- •Dysphagia grade ≥3 (able to swallow only liquid foods)
- •History of myocardial infarction or other cardiovascular event within 6 months of enrolment
- •Neurological diseases associated with impaired swallowing
- •Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).
结局指标
主要结局
Discovery of suitable biomarkers for squamous intraepithelial neoplasia to inform future trials.
时间窗: 4 years
RNA-seq expression analysis will be used to measure the abundance of the previously identified biomarkers of squamous intraepithelial neoplasia, including genes TP53, NFE2L2, MLL2, ZNF750, NOTCH1, TFNAIP3, and CHN1. The study will include these biomarkers, but will not be limited to them.
次要结局
- Safety of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC: rate of Participants with adverse events within 30 days after application(4 years)
- Acceptability of the Cytosponge™ cell collection device in patients with ESCC and high-risk for ESCC(4 years)
研究者
Wladyslaw Januszewicz
Principal Investigator
Centre of Postgraduate Medical Education