Application and Promotion of the Whole-process Management and Precision Diagnosis and Treatment System for Hydatidiform Mole: a Multi-center Cohort Study in China (CN-HM-01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,489
- 试验地点
- 14
- 主要终点
- Malignant transformation of hydatidiform mole
研究概览
简要总结
This observational study aims to establish a national cohort of patients with hydatidiform mole (molar pregnancy) to investigate its malignant transformation rate and malignant transformation mechanisms, with the goal of developing and promoting precision diagnosis and treatment models across China.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically or pathologically diagnosed as hydatidiform mole.
- •Availability of complete medical records, including clinical and pathological data.
- •No evidence of myometrial invasion or metastasis.
- •Serum hCG levels normalized after uterine evacuation with at least 6 months of follow-up, OR diagnosed with postmolar gestational trophoblastic neoplasia (pGTN) during follow-up.
- •No history of psychiatric disorders, serious infectious diseases, or immune system diseases (such as systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).
- •Willing to participate in this study and sign the relevant informed consent form.
排除标准
- •Missing clinical data.
- •Loss to follow-up: Do not return to participating hospital for follow-up visits after uterine evacuation, or could not be contacted for subsequent monitoring of hCG changes.
- •Concomitant malignancies or autoimmune deficiency disorders (e.g., systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).
- •As determined by the investigator, the presence of medical, psychological, social, occupational, or other conditions that would violate the study protocol or impair the subject's ability to provide informed consent.
结局指标
主要结局
Malignant transformation of hydatidiform mole
时间窗: Postoperative b-hCG levels were monitored every 1-2 weeks. While patients with PHM could discontinue follow-up after b-hCG normalization, those with CHM- given their higher risk of malignant progression- require monthly monitoring for 6 months following
Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
次要结局
- Fertility outcomes(1 year and 2 year)
- Hospital Anxiety and Depression Scale (HADS)(Pathological diagnosis, 3 months after uterine evacuation)
- Reproductive Concerns After Cancer (RCAC)(Pathological diagnosis, 3 months after uterine evacuation)
研究者
Xin Lu
Director of Chemotherapy Unit, Gynecologic Oncology Department, Obstetrics and Gynecology Hospital,
Obstetrics & Gynecology Hospital of Fudan University