A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)

Официальное название

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)

Обзор

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.

Вмешательства

• Другое No intervention
  No intervention

Первичные конечные точки

• Malignant transformation of hydatidiform mole [Срок оценки: 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]

Вторичные конечные точки (3)

• Fertility outcomes [Срок оценки: 1 year and 2 year]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Pathological diagnosis, 3 months after uterine evacuation]
• Reproductive Concerns After Cancer (RCAC) [Срок оценки: Pathological diagnosis, 3 months after uterine evacuation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 14 центров

• Gansu Province Maternal and Child Care Hospital — Lanzhou
• Shenzhen Maternity & Child Healthcare Hospital — Шэньчжэнь
• Hainan women and children medical center — Haikou
• Hebei Medical University Third Hospital — Shijiazhuang
• Third Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Dalian Women and Children medical Center — Dalian
• Shengjing Hospital of China Medical University — Шэньян
• Center for Reproductive Medicine, Shandong University — Цзинань
• … и ещё 6 центров

Идентификаторы

NCT: NCT07202728 · 2025-109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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