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NCT Number: NCT07202728

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Gansu Province Maternal and Child Care Hospital, Lanzhou, Gansu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Malignant transformation of hydatidiform mole

    Time frame: 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

  1. Fertility outcomes

    Time frame: 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.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Pathological diagnosis, 3 months after uterine evacuation

    ordinal scale, range: 0-3, higher scores means a worse outcome

  3. Reproductive Concerns After Cancer (RCAC)

    Time frame: Pathological diagnosis, 3 months after uterine evacuation

    ordinal scale, range: 1-5, higher scores mean a better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Lu, MD & PhD

CONTACT

[email protected]

+86-021-33189900

Yan Du, DrPH

CONTACT

[email protected]

+86-021-33189900

Sponsors and collaborators

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University

Other

Collaborators

  • Dalian Women and Children's Medical Center
  • First Affiliated Hospital of Zhejiang University
  • Gansu Provincial Maternal and Child Health Care Hospital
  • Hainan women and children medical center
  • Hebei Medical University Third Hospital
  • International Peace Maternity and Child Health Hospital
  • Peking Union Medical College Hospital
  • Shandong University
  • Shanghai First Maternity and Infant Hospital
  • Shengjing Hospital
  • Shenzhen Maternity & Child Healthcare Hospital
  • The Affiliated Hospital of Qingdao University
  • Third Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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)

Acronym: CN-HM-01

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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