A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Hydatidiform Mole. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Fertility outcomes [Time frame: 1 year and 2 year]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Pathological diagnosis, 3 months after uterine evacuation]
- Reproductive Concerns After Cancer (RCAC) [Time frame: Pathological diagnosis, 3 months after uterine evacuation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 14 centers
- Gansu Province Maternal and Child Care Hospital — Lanzhou
- Shenzhen Maternity & Child Healthcare Hospital — Shenzhen
- Hainan women and children medical center — Haikou
- Hebei Medical University Third Hospital — Shijiazhuang
- Third Affiliated Hospital of Zhengzhou University — Zhengzhou
- Dalian Women and Children medical Center — Dalian
- Shengjing Hospital of China Medical University — Shenyang
- Center for Reproductive Medicine, Shandong University — Jinan
- … and 6 more centers
Identifiers
NCT: NCT07202728 · 2025-109