RecruitingNot Applicable

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

China1,489 participantsStarted 2025-07-09

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Malignant transformation of hydatidiform mole

Timeframe: 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

Trial details

NCT IDNCT07202728

SponsorObstetrics & Gynecology Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-30

Contact for this trial

Xin Lu, MD & PhD

+86-021-33189900 xin_lu@fudan.edu.cn

View on ClinicalTrials.gov More Hydatidiform Mole trials