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

Obstetrics & Gynecology Hospital of Fudan University

Status: Enrolling

Conditions: Hydatidiform Mole

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07202728

2025-109

Details and patient eligibility

About

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.

Enrollment: 1,489 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,489 participants in 1 patient group

Hydatidiform mole

Description:

This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy.

Treatment:

Other: No intervention