National multicenter cohort of molar pregnancy in China
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)
Run by Obstetrics & Gynecology Hospital of Fudan University · NCT07202728 · Data updated 2026-11-12
This project will see how often molar pregnancy turns into cancer and which clinical or pathological factors predict that, by following patients across multiple hospitals in China.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 1489 (estimated) |
| Sponsor | Obstetrics & Gynecology Hospital of Fudan University Academic / other |
| Locations | 14 sites (Lanzhou, Gansu and 13 other locations) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | August 30, 2028 |
| Study ends | August 30, 2030 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07202728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People clinically or pathologically diagnosed with hydatidiform mole who have complete medical records, no myometrial invasion or metastasis, normalized hCG after uterine evacuation with at least six months of follow-up or a documented pGTN during follow-up, no major psychiatric/infectious/immune disorders, and who consent to participate are eligible.
✕Probably not a fit
Patients with missing clinical data, loss to follow-up, concurrent malignancies or immune deficiency disorders, or established invasive/metastatic disease are unlikely to benefit from this cohort.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter observational cohort that enrolls patients diagnosed with hydatidiform mole and collects complete clinical and pathological records. Participants are followed with serial serum hCG monitoring after uterine evacuation for at least six months, or until a diagnosis of postmolar gestational trophoblastic neoplasia (pGTN) if it occurs. The study aims to measure malignant transformation rates and to characterize mechanisms and risk factors underlying progression. Findings will be used to develop and promote more precise diagnosis and management pathways for molar pregnancy across China.
Why it matters
Potential benefit: If successful, the project could enable earlier detection of malignant transformation and more individualized follow-up and treatment strategies for people with molar pregnancy.
How similar studies have gone: Smaller regional cohorts and registries have reported variable malignant transformation rates and identified some risk factors, but a large national multicenter cohort of this scale in China is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinically or pathologically diagnosed as hydatidiform mole. 2. Availability of complete medical records, including clinical and pathological data. 3. No evidence of myometrial invasion or metastasis. 4. 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. 5. No history of psychiatric disorders, serious infectious diseases, or immune system diseases (such as systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.). 6. Willing to participate in this study and sign the relevant informed consent form. Exclusion Criteria: 1. Missing clinical data. 2. 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. 3. Concomitant malignancies or autoimmune deficiency disorders (e.g., systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.). 4. 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.
Where it's running
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Gansu Province Maternal and Child Care Hospital
Lanzhou, Gansu, China Recruiting -
Hainan women and children medical center
Haikou, Hainan, China Recruiting -
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Peking Union Medical College Hospital
Beijing, China Recruiting -
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, China Not yet recruiting -
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China Not yet recruiting
Show 8 more locations
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Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Not yet recruiting -
Dalian Women and Children medical Center
Dalian, Liaoning, China Not yet recruiting -
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China Not yet recruiting -
Center for Reproductive Medicine, Shandong University
Jinan, Shandong, China Not yet recruiting -
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China Not yet recruiting -
Shanghai First Maternity and Infant Hospital
Shanghai, Shandong, China Not yet recruiting -
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China Not yet recruiting -
International Peace Maternity and Child Health Hospital
Shanghai, China Not yet recruiting
Study contacts
- Study coordinator: Xin Lu, MD & PhD
- Email: xin_lu@fudan.edu.cn
- Phone: +86-021-33189900
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.