RecruitingNCT07202728

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

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)


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

1,489 participants

Start Date

Jul 9, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

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Interventions

OTHERNo intervention

No intervention


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

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Peking Union Medical College Hospital

Beijing, China

International Peace Maternity and Child Health Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07202728


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