jRCT1042240025招募中不适用
A randomized controlled trial of Endoscopic surVEillance with NBI or iodine staining for patients after Endoscopic RESecTion of esophageal squamous cell carcinoma
未提供0 个研究点目标入组 1,700 人开始时间: 2024年11月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,700
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 80age old under(—)
- 性别
- All
入选标准
- •(1) Upper gastrointestinal endoscopy for surveillance after endoscopic resection of histopathologically diagnosed primary esophageal squamous cell carcinoma (ESCC) is planned.
- •(2) Histopathology of all endoscopic resections was pT1a, negative for lymphovascular invasion, and negative for vertical margin.
- •(3) The previous upper gastrointestinal endoscopy with iodine staining of the entire esophagus was performed within 6 months, and all histopathologically diagnosed ESCCs were endoscopically resected.
- •(4) Additional treatment is not planned after endoscopic resection of ESCC.
- •(5) No previous treatment for ESCC other than endoscopic resection.
- •(6) No previous radiation therapy for the chest, lung field, or mediastinum for any cancer types.
- •(7) No previous surgery for the esophagus or mediastinum including for benign tumors.
- •(8) No pharyngeal or esophageal stricture where the standard endoscope cannot pass.
- •(9) Age between 18 and 80 years.
- •(10) An Eastern Cooperative Oncology Group Performance Status of 0 or
- •(11) Endoscopic surveillance for 3 years after registration is considered feasible.
- •(12) Provision of written informed consent for participation in the trial.
排除标准
- •(1) Other primary cancers within the previous 5 years except intramucosal tumors cured with local therapy.
- •(2) A history of iodine allergy.
- •(3) Severe mental disease.
- •(4) The investigator considered ineligible as subjects.
结局指标
主要结局
-
Targeted ESCC-free survival
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
PRECIOUS trialJPRN-UMIN000021514Aichi cancer center hospital370
进行中(未招募)
1 期
A Phase 1/2a Study of Safety, Pharmacokinetics and Neutralizing Activity of SPK002 as pre-exposure prophylaxis of COVID-19 in healthy volunteers (Phase 1) and immunocompromised individuals (Phase 2a).Immunocompromised individuals (phase 2a), Healthy volunteers (Phase 1)MedDRA version: 23.0Level: PTClassification code: 10084458Term: COVID-19 prophylaxis Class: 100000004865CTIS2023-505279-62-00Spikimm78
招募中
不适用
GINGA trialjRCTs03124034520
招募中
不适用
EVOLUTION trialulcerative colitisjRCTs031240498134
招募中
不适用
LEDGIM trialjRCTs041240116260
