Clinical Specialty Queue For Gestational Trophoblastic Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Collect disease-related clinical and pathological features of the included subjects
研究概览
简要总结
The aim of this study is to establish a bidirectional cohort study of GTN specific diseases, including 1020 retrospective cases Queue and 1000 prospective cohorts. Based on the clinical collaboration system for gynecological tumors in multiple tertiary hospitals across the country, establish unified criteria for case inclusion and exclusion, and establish a multi center clinical queue for GTN; Collect baseline information of GTN patients, such as age, reproductive history, environmental and social information, genetic related information, physical examination, physicochemical, imaging, and pathological information; Collect biological specimens such as blood/tissue from patients; Collect information related to the diagnosis, treatment plan, human chorionic gonadotropin (hCG) levels, and toxic side effects of patients during the diagnosis and treatment period; After the end of treatment, follow-up blood hCG levels, imaging, fertility status, as well as recurrence and metastasis status, are conducted to track prognosis, thus building a clinical diagnosis and treatment information database, forming a standardized follow-up system for GTN, identifying high-risk factors for GTN chemotherapy resistance, constructing a precise evaluation model for GTN resistance, and providing high-level evidence-based medicine for effectively improving the initial treatment efficacy of GTN.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •① Age ≥ 18 years old; ② Patients clinically diagnosed with GTN (including invasive cases) Molar pregnancy, choriocarcinoma, PSTT, ETT); ③ Complete informed consent for enrollment.
排除标准
- •① Having mental illness or cognitive impairment, unable to cooperate in completing the investigation with Patients with concurrent malignant tumors; ③ Participants with severe missing follow-up data.
结局指标
主要结局
Collect disease-related clinical and pathological features of the included subjects
时间窗: GTN should be closely followed up after treatment, with monthly follow-up once in the first year and 2-3 days Follow up once every 3 months annually for a total of 5 years.
Collect baseline information of GTN patients, such as age, reproductive history,environmental and social information, genetic related information, physical examination, physicochemical, imaging, and pathological information; Collect biological specimens such as blood/tissue from patients; Collect information on the diagnosis, treatment plan, levels of human chorionic gonadotropin, and toxic side effects of patients during the diagnosis and treatment period.
次要结局
未报告次要终点
研究者
Weiguo Lv
Doctor
Women's Hospital School Of Medicine Zhejiang University
