Evaluation of a Non-Endoscopic Immunocytological Device (Cytosponge™) for Post Chemo-radiotherapy Surveillance in Patients With Oesophageal Cancer -a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Completion Rate
研究概览
简要总结
This is a feasibility study testing the use of the Cytosponge™ device in patients with known oesophageal cancer treated with pre-operative or definitive chemoradiation. All participants will receive one Cytosponge™ procedure at one time-point within 4-16 weeks after completion of chemoradiotherapy.
详细描述
In this feasibility study, we are investigating a novel way to test for remaining or reoccurring oesophageal cancer following chemoradiotherapy. The technique used to test this is called a Cytosponge™. We will be testing the use of the Cytosponge™ to determine completion rate, safety and acceptability of the procedure.
Cytosponge™ is a capsule-sized device which contains an expandable, spherical mesh which is attached to a string. The capsule dissolves in the stomach after swallowing, releasing the sponge which is then retrieved by gently pulling the string after five minutes. As the sponge is pulled out it collects the cells from the lining of the gullet.
The Cytosponge™ will be processed for evidence of residual cancer through analysis of cellular atypia and molecular biomarkers. Where available, the results will be compared with histology.
Up to fifty patients will be recruited to the trial across 11 sites.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, Age >/=16 years who
- •have undergone pre-operative CRT as treatment for oesophageal cancer and due to undergo oesophagectomy or
- •have undergone definitive CRT as treatment for oesophageal cancer
- •4-16 weeks post completion of CRT
- •Dysphagia score 0-2 (Mellow Scale)*
- •Able to swallow tablets
- •Physiologically fit for endoscopy
- •Written (signed and dated) informed consent
- •The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
排除标准
- •Known to have oesophageal varices or stricture requiring dilatation of the oesophagus.
- •Unable to temporarily discontinue anticoagulation therapy/medication prior to their procedure*
- •Oesophageal stent
- •Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
- •Patients on anti-coagulation therapy are eligible for the study as long as they are considered suitable candidates for endoscopic biopsy (follow local hospital procedures for management of patients on anticoagulation due to undergo endoscopy). If temporary discontinuation of anticoagulation is required, this should be after consultation with the patients clinical care team.
结局指标
主要结局
Completion Rate
时间窗: Day 1 following intervention
The percentage of consented, evaluable patients successfully undergoing the Cytosponge™ procedure.
次要结局
- Safety; Number of SAEs Related to the Device Procedure(Two week follow up)
- Number of Participants With Positive Cytosponge™ Results From Biomarker Analysis (i.e. Presence of Cytological Atypia and/or p53 Abnormality)(From sample taken from Cytosponge™ on day of intervention)
- Acceptance Rate(Day 1 after questionnaire completion)
- Number of Patients Who Would be Prepared to Repeat the Procedure(Day 1 after questionnaire completion)