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临床试验/NCT06681259
NCT06681259招募中不适用

Clinical Specialty Queue For Gestational Trophoblastic Neoplasia

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年11月4日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiguo Lv

Doctor

Women's Hospital School Of Medicine Zhejiang University

研究点 (1)

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