Study Into Treatment of Hyperplasia of Mammary Glands
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands
研究概览
简要总结
Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.
详细描述
Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reported breast pain or breast lumps.
- •Willing to be kept follow-up.
- •Functions below are maintained in major organs: liver, renal and heart.
- •Written informed consent will be obtained for patients for entering this study.
排除标准
- •Typical breast cancer or fibroadenoma.
- •Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS)
- •Oral contraceptive or hormone replacement therapy.
- •History of breast cancer or other malignancies.
- •History of pituitary gland disease.
- •Potentially pregnant, pregnant, or breast-feeding.
结局指标
主要结局
Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands
时间窗: 8 months
次要结局
- Clinical manifestations as an surgical indications for hyperplasia of mammary glands(8 months)
研究者
Yu-Zhi Gang
Chief of Department of Breast Surgery
Shandong University