NCT03812939Unknown不适用
An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of gastric neuroendocrine tumor.
- •Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
- •Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
- •No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
- •SSA therapy is recommended by physician for disease management, and has not yet begun.
- •Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.
排除标准
- •Pathological grading as G3 NET (Ki-67>20%).
- •Patients with a known hypersensitivity to somatostatin analogs.
- •Known gallbladder or bile duct disease, acute or chronic pancreatitis.
- •Known medical condition related with prolonged QT interval.
- •Pregnant or lactating women.
- •Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
- •Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
- •Patients with a history of non-compliance to medical regimens.
结局指标
主要结局
Recurrence rate
时间窗: 1 year
次要结局
- Change in clinical symptoms(6 months to 1 year)
- Concentration of serum Gastrin(6 months to 1 year)
- Enterochromaffin-like cell (ECL) status(6 months to 1 year)
- Presence of side-effects of Octreotide(6 months to 1 year)
研究者
Jing-Nan Li
Head of Gastroenterology
Peking Union Medical College Hospital
研究点 (1)
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