A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
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)
1 other identifier
observational
1,489
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2025
CompletedFirst Submitted
Initial submission to the registry
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2030
October 2, 2025
September 1, 2025
3.1 years
September 16, 2025
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Malignant transformation of hydatidiform mole
Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
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 Outcomes (3)
Fertility outcomes
1 year and 2 year
Hospital Anxiety and Depression Scale (HADS)
Pathological diagnosis, 3 months after uterine evacuation
Reproductive Concerns After Cancer (RCAC)
Pathological diagnosis, 3 months after uterine evacuation
Study Arms (1)
Hydatidiform mole
This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy.
Interventions
Eligibility Criteria
This study will enrol women with a confirmed hydatidiform mole who have undergone uterine evacuation. Candidates must possess complete clinical and pathological records and show no myometrial invasion or distant metastasis at baseline. We will exclude those with concurrent malignancy, severe autoimmune or infectious disease, or significant psychiatric illness. Longitudinal follow-up will track malignant transformation (post-molar gestational trophoblastic neoplasia per FIGO criteria), reproductive outcomes, and health-related quality of life. By establishing a large, nationwide, multicentre cohort, we aim to clarify the epidemiology, pinpoint risk factors for malignant progression, and evaluate long-term reproductive and psychosocial outcomes in this population.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Obstetrics & Gynecology Hospital of Fudan Universitylead
- Peking Union Medical College Hospitalcollaborator
- Shengjing Hospitalcollaborator
- Hebei Medical University Third Hospitalcollaborator
- Hainan women and children medical centercollaborator
- Shenzhen Maternity & Child Healthcare Hospitalcollaborator
- Third Affiliated Hospital of Zhengzhou Universitycollaborator
- Shanghai First Maternity and Infant Hospitalcollaborator
- International Peace Maternity and Child Health Hospitalcollaborator
- Shandong Universitycollaborator
- First Affiliated Hospital of Zhejiang Universitycollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
- Gansu Provincial Maternity and Child-care Hospital/Gansu Provincial Central Hospitalcollaborator
- Dalian women and children's medical groupcollaborator
Study Sites (14)
Gansu Province Maternal and Child Care Hospital
Lanzhou, Gansu, 730050, China
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, 518028, China
Hainan women and children medical center
Haikou, Hainan, 570311, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051, China
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Dalian Women and Children medical Center
Dalian, Liaoning, 116038, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Center for Reproductive Medicine, Shandong University
Jinan, Shandong, 250021, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shandong, 201204, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Peking Union Medical College Hospital
Beijing, 100730, China
International Peace Maternity and Child Health Hospital
Shanghai, 200030, China
Biospecimen
1. Peripheral blood (5mL): Collected from hydatidiform mole patients in EDTA tubes for whole-genome sequencing. 2. Uterine evacuation tissue: Selectively obtained from suspected cases for single-cell sequencing. Samples are tripartite: RNAlater (scRNA-seq), frozen (-80°C), or formalin-fixed (pathology). All samples are collected after obtaining informed consent, and stored under strict ethical guidelines.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xin Lu, MD & PhD
Obstetrics & Gynecology Hospital of Fudan University
- STUDY CHAIR
Yang Xiang, MD & PhD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Chemotherapy Unit, Gynecologic Oncology Department, Obstetrics and Gynecology Hospital,
Study Record Dates
First Submitted
September 16, 2025
First Posted
October 2, 2025
Study Start
July 9, 2025
Primary Completion (Estimated)
August 30, 2028
Study Completion (Estimated)
August 30, 2030
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share