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

Recruiting

• Conditions: Hydatidiform Mole

• Registration Number: NCT07202728
• Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-09
• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2028-08-30
• Study Completion: 2030-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1489

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignant transformation of hydatidiform mole	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	Diagnosed with pGTN according to the FIGO guideline diagnostic criteria

Secondary Outcome Measures

Name	Time	Method
Fertility outcomes	1 year and 2 year	Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy.
Hospital Anxiety and Depression Scale (HADS)	Pathological diagnosis, 3 months after uterine evacuation	ordinal scale, range: 0-3, higher scores means a worse outcome
Reproductive Concerns After Cancer (RCAC)	Pathological diagnosis, 3 months after uterine evacuation	ordinal scale, range: 1-5, higher scores mean a better outcome

Trial Locations

Locations (14)

Gansu Province Maternal and Child Care Hospital; 🇨🇳 Lanzhou, Gansu, China

Shenzhen Maternity & Child Healthcare Hospital; 🇨🇳 Shenzhen, Guangdong, China

Hainan women and children medical center; 🇨🇳 Haikou, Hainan, China

Hebei Medical University Third Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Dalian Women and Children medical Center; 🇨🇳 Dalian, Liaoning, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Center for Reproductive Medicine, Shandong University; 🇨🇳 Jinan, Shandong, China

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shandong, China

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