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

RECRUITINGSponsored by Obstetrics & Gynecology Hospital of Fudan University
Actively Recruiting
SponsorObstetrics & Gynecology Hospital of Fudan University
Started2025-07-09
Est. completion2028-08-30
Eligibility
Age18 Years – 60 Years
SexFEMALE
Healthy vol.Accepted

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 mechanisms, with the goal of developing and promoting precision diagnosis and treatment models across China.

Eligibility

Age: 18 Years – 60 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. Clinically or pathologically diagnosed as hydatidiform mole.
2. Availability of complete medical records, including clinical and pathological data.
3. No evidence of myometrial invasion or metastasis.
4. 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.
5. No history of psychiatric disorders, serious infectious diseases, or immune system diseases (such as systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).
6. Willing to participate in this study and sign the relevant informed consent form.

Exclusion Criteria:

1. Missing clinical data.
2. 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.
3. Concomitant malignancies or autoimmune deficiency disorders (e.g., systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).
4. 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.

Conditions2

CancerHydatidiform Mole

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