NCT07202728 A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
| NCT ID | NCT07202728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Obstetrics & Gynecology Hospital of Fudan University |
| Condition | Hydatidiform Mole |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,489 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2028-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,489 participants in total. It began in 2025-07-09 with a primary completion date of 2028-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Xin Lu, MD & PhD
STUDY CHAIR
Obstetrics & Gynecology Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT07202728 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Hydatidiform Mole. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202728 currently recruiting?
Yes, NCT07202728 is actively recruiting participants. Contact the research team at xin_lu@fudan.edu.cn for enrollment information.
Where is the NCT07202728 trial being conducted?
This trial is being conducted at Lanzhou, China, Shenzhen, China, Haikou, China, Shijiazhuang, China and 10 additional locations.
Who is sponsoring the NCT07202728 clinical trial?
NCT07202728 is sponsored by Obstetrics & Gynecology Hospital of Fudan University. The principal investigator is Xin Lu, MD & PhD at Obstetrics & Gynecology Hospital of Fudan University. The trial plans to enroll 1,489 participants.