Status:
RECRUITING
A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
Lead Sponsor:
Obstetrics & Gynecology Hospital of Fudan University
Collaborating Sponsors:
Peking Union Medical College Hospital
Shengjing Hospital
Conditions:
Hydatidiform Mole
Eligibility:
FEMALE
18-60 years
Brief Summary
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 mechanis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
1489 Patients enrolled
Trial Details
Trial ID
NCT07202728
Start Date
July 9 2025
End Date
August 30 2030
Last Update
October 2 2025
Active Locations (14)
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1
Gansu Province Maternal and Child Care Hospital
Lanzhou, Gansu, China, 730050
2
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, China, 518028
3
Hainan women and children medical center
Haikou, Hainan, China, 570311
4
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China, 050051