National multicenter cohort of molar pregnancy in China

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)

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
• Enrollment: 1489 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (other)
• Locations: 14 sites (Lanzhou, Gansu and 13 other locations)
• Trial ID: NCT07202728 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Lanzhou, Gansu and 13 other locations

• Gansu Province Maternal and Child Care Hospital — Lanzhou, Gansu, China (RECRUITING)
• Shenzhen Maternity & Child Healthcare Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Hainan women and children medical center — Haikou, Hainan, China (RECRUITING)
• Hebei Medical University Third Hospital — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• 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)
• Obstetrics & Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• Peking Union Medical College Hospital — Beijing, China (RECRUITING)
• International Peace Maternity and Child Health Hospital — Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Xin Lu, MD & PhD

Conditions: Hydatidiform Mole, Observational Study