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

NCT07202728 — Recruiting, 1489 participants, Obstetrics & Gynecology Hospital of Fudan University

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Application and Promotion of the Whole-process Management and Precision Diagnosis and Treatment System for Hydatidiform Mole: a Multi-center Cohort Study in China (CN-HM-01)

Registry	NCT07202728, acronym CN-HM-01
Status	Recruiting
Study type	Observational
Enrollment	1489 (Estimated)
Sponsor	Obstetrics & Gynecology Hospital of Fudan University (Other); collaborators: Peking Union Medical College Hospital, Shengjing Hospital, Hebei Medical University Third Hospital, Hainan women and children medical center, Shenzhen Maternity & Child Healthcare Hospital, Third Affiliated Hospital of Zhengzhou University, Shanghai First Maternity and Infant Hospital, International Peace Maternity and Child Health Hospital, Shandong University, First Affiliated Hospital of Zhejiang University, The Affiliated Hospital of Qingdao University, Gansu Provincial Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center
Conditions	Hydatidiform Mole
Interventions	No intervention (Other)
Dates	start 2025-07-09, primary completion 2028-08-30 (estimated), completion 2030-08-30 (estimated), first posted 2025-10-02, last updated 2025-10-02
Locations	14 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Hydatidiform mole		Other: No intervention	This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy.

No intervention (Other): No intervention

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 60 Years

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.

+Locations (14)

Facility	City	Country	Status
Gansu Province Maternal and Child Care Hospital	Lanzhou, Gansu	China	Recruiting
Shenzhen Maternity & Child Healthcare Hospital	Shenzhen, Guangdong	China	Not yet recruiting
Hainan women and children medical center	Haikou, Hainan	China	Recruiting
Hebei Medical University Third Hospital	Shijiazhuang, Hebei	China	Not yet recruiting
Third Affiliated Hospital of Zhengzhou University	Zhengzhou, Henan	China	Not yet recruiting
Dalian Women and Children medical Center	Dalian, Liaoning	China	Not yet recruiting
Shengjing Hospital of China Medical University	Shenyang, Liaoning	China	Not yet recruiting
Center for Reproductive Medicine, Shandong University	Jinan, Shandong	China	Not yet recruiting
The Affiliated Hospital of Qingdao University	Qingdao, Shandong	China	Not yet recruiting
Shanghai First Maternity and Infant Hospital	Shanghai, Shandong	China	Not yet recruiting
Obstetrics & Gynecology Hospital of Fudan University	Shanghai, Shanghai Municipality	China	Recruiting
First Affiliated Hospital of Zhejiang University	Hangzhou, Zhejiang	China	Not yet recruiting
Peking Union Medical College Hospital	Beijing	China	Recruiting
International Peace Maternity and Child Health Hospital	Shanghai	China	Not yet recruiting

+Investigators

Xin Lu, MD & PhD, Study chair, Obstetrics & Gynecology Hospital of Fudan University
Yang Xiang, MD & PhD, Study chair, Peking Union Medical College Hospital