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Age: 18Years - 60Years
FEMALE
ID07202728

A Nationwide Study on Managing and Diagnosing Hydatidiform Mole with Precision in China

Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-10-02

1489

Participants Needed

14

Research Sites

104 weeks

Total Duration

On this page

Sponsors

O

Obstetrics & Gynecology Hospital of Fudan University

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a nationwide observational study in China to create a detailed group of patients diagnosed with hydatidiform mole, a type of molar pregnancy. The studys main focus is to understand how often these moles become cancerous and to explore the mechanisms behind this transformation. The goal is to improve and spread precise diagnosis and treatment methods for this condition across the country. This study involves closely monitoring patients without providing any additional treatment, supporting the development of evidence-based care strategies for molar pregnancy. Patients will have their beta-hCG hormone levels checked regularly after uterine evacuation to watch for signs of malignant changes. Those with partial hydatidiform mole can stop follow-up once hormone levels normalize, while patients with complete hydatidiform mole will be monitored monthly for six months due to a higher risk of progression. Participants will undergo regular clinical and pathological evaluations, including hormone monitoring every 1-2 weeks post-surgery. Researchers will also assess fertility outcomes at one and two years and measure psychological well-being using anxiety, depression, and reproductive concern scales three months after uterine evacuation. Follow-up will continue for at least six months to track any malignant changes, with the total study duration extending up to several years depending on individual patient progress.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 during follow-up.
  • No history of psychiatric disorders, serious infectious diseases, or immune system diseases such as systemic lupus erythematosus, myasthenia gravis, or HIV infection.
  • Willing to participate in this study and sign the informed consent form.
Not Eligible

You will not qualify if you...

  • Missing clinical data.
  • Loss to follow-up: not returning for follow-up visits after uterine evacuation or being unreachable for hCG monitoring.
  • Concomitant malignancies or autoimmune deficiency disorders such as systemic lupus erythematosus, myasthenia gravis, or HIV infection.
  • Medical, psychological, social, occupational, or other conditions that would violate the study protocol or impair ability to provide informed consent as determined by the investigator.

Research Team

X

Xin Lu, MD & PhD

Y

Yan Du, DrPH

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