Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease progression or recurrence after surgery
研究概览
简要总结
As the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15% of them are resistant to conventional treatments such as surgery, drug therapy and radiotherapy, and often relapse or regrow in the early postoperative period, which is invasive and has a poor prognosis. Therefore, it is important to find imaging, histological or serum molecular markers for early prediction of the invasiveness and clinical prognosis of pituitary neuroendocrine tumors. The aim of this study is to observe the changes of biomarkers and imaging features in serum or tissues of pituitary neuroendocrine tumors during the course of disease and treatment, and to explore the biomarkers and imaging features that can predict the proliferation, progression and recurrence risk of pituitary neuroendocrine tumors after medical or surgical treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical imaging, with or without pituitary hormone secretion function was confirmed by pituitary hormone detection.
排除标准
- •Previous pathological specimen suggested pituitary carcinoma.
- •always have received radiation and chemotherapy or immune and targeted therapy of the patients.
- •with known genetic syndrome can cause excessive secretion of hormones (such as Carney syndrome, McCune - Albright syndrome, multiple endocrine neoplasia type 1, acute interstitial pneumonia) patients.
- •there are ectopic neuroendocrine tumor patients.
- •within one month before the screening for major surgery, or within 3 months before screening for patients with sphenoid pituitary surgery.
- •crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis).
- •peripheral glands or other solid tumors in patients with severe disease or blood system.
- •serious organ damage such as heart, kidney, liver, etc.
- •with severe mental or nervous system disease.
- •serious high blood glucose or poorly controlled hypertension or emergency patients.
结局指标
主要结局
Disease progression or recurrence after surgery
时间窗: up to 5 years
Disease'recurrence'corresponded to tumour detection at MRI and/or hormone hypersecretion in previously cured patients, while disease'progression'indicated the increase in size of post-operative tumour remnant in nonfunctioning tumours and/or relapse of hormone hypersecretion in functioning ones
次要结局
未报告次要终点
研究者
Yanbing Li
director of endocrinology department
Sun Yat-sen University