Actively Recruiting
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)
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-10-02
1489
Participants Needed
14
Research Sites
104 weeks
Total Duration
On this page
Sponsors
O
Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a nationwide observational study in China to create a detailed group of patients diagnosed with hydatidiform mole, a type of molar pregnancy. The study's main focus is to understand how often these moles become cancerous and to explore the mechanisms behind this transformation. The goal is to improve and spread precise diagnosis and treatment methods for this condition across the country. This study involves closely monitoring patients without providing any additional treatment, supporting the development of evidence-based care strategies for molar pregnancy. Patients will have their beta-hCG hormone levels checked regularly after uterine evacuation to watch for signs of malignant changes. Those with partial hydatidiform mole can stop follow-up once hormone levels normalize, while patients with complete hydatidiform mole will be monitored monthly for six months due to a higher risk of progression. Participants will undergo regular clinical and pathological evaluations, including hormone monitoring every 1-2 weeks post-surgery. Researchers will also assess fertility outcomes at one and two years and measure psychological well-being using anxiety, depression, and reproductive concern scales three months after uterine evacuation. Follow-up will continue for at least six months to track any malignant changes, with the total study duration extending up to several years depending on individual patient progress.
CONDITIONS
Brief Title
A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 during follow-up.
- No history of psychiatric disorders, serious infectious diseases, or immune system diseases such as systemic lupus erythematosus, myasthenia gravis, or HIV infection.
- Willing to participate in this study and sign the informed consent form.
You will not qualify if you...
- Missing clinical data.
- Loss to follow-up: not returning for follow-up visits after uterine evacuation or being unreachable for hCG monitoring.
- Concomitant malignancies or autoimmune deficiency disorders such as systemic lupus erythematosus, myasthenia gravis, or HIV infection.
- Medical, psychological, social, occupational, or other conditions that would violate the study protocol or impair ability to provide informed consent as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants undergo clinical or pathological diagnosis of hydatidiform mole and have medical records reviewed to confirm eligibility.
1 to 2 visits depending on diagnostic procedures
Duration - 6 months or longer depending on risk and follow-up needs
Participants are monitored post-uterine evacuation with serum b-hCG levels checked every 1-2 weeks initially; those with complete hydatidiform mole undergo monthly monitoring for 6 months due to higher risk of malignant progression.
Weekly to biweekly visits initially, then monthly visits for up to 6 months
Duration - Up to 2 years
Participants complete assessments of fertility outcomes at 1 and 2 years, and complete psychological evaluations including Hospital Anxiety and Depression Scale and Reproductive Concerns After Cancer questionnaires 3 months after uterine evacuation.
3 visits post-uterine evacuation over 2 years
Trial Site Locations
Total: 14 locations
1
Gansu Province Maternal and Child Care Hospital
Lanzhou, Gansu, China, 730050
Actively Recruiting
2
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, China, 518028
Not Yet Recruiting
3
Hainan women and children medical center
Haikou, Hainan, China, 570311
Actively Recruiting
4
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China, 050051
Not Yet Recruiting
5
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
6
Dalian Women and Children medical Center
Dalian, Liaoning, China, 116038
Not Yet Recruiting
7
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
8
Center for Reproductive Medicine, Shandong University
Jinan, Shandong, China, 250021
Not Yet Recruiting
9
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
10
Shanghai First Maternity and Infant Hospital
Shanghai, Shandong, China, 201204
Not Yet Recruiting
11
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090
Actively Recruiting
12
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
13
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
14
International Peace Maternity and Child Health Hospital
Shanghai, China, 200030
Not Yet Recruiting
Research Team
X
Xin Lu, MD & PhD
Y
Yan Du, DrPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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