The Effect of Ablation Therapy on Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus
详细描述
To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
- •Ability to provide informed consent
排除标准
- •Eastern Cooperative Oncology Group performance status 3 or 4
- •Inability to tolerate endoscopic procedures
- •Pregnancy: Females of child-bearing age will be screened with pregnancy test.
研究组 & 干预措施
1
Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study
干预措施: Biopsy (Other)
结局指标
主要结局
Response to treatment
时间窗: at time of surveillance intervals
presence of persistent or recurrence of barrett's esophagus and/or dysplasia
次要结局
未报告次要终点
研究者
Cadman Leggett
Principal Investigator
Mayo Clinic