Clinical trial Recruiting at 4 sites Observational Ages 18 to 60 Women only

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.

More Hydatidiform Mole trials

Quick facts

Study typeObservational
Ages18 Years to 60 Years
SexWomen only
Enrollment1489 (estimated)
SponsorObstetrics & Gynecology Hospital of Fudan University
Academic / other
Locations14 sites (Lanzhou, Gansu and 13 other locations)
StatusRecruiting
StartedJuly 9, 2025
Main results expectedAugust 30, 2028
Study endsAugust 30, 2030
Registry record updatedOctober 2, 2025
Trial IDNCT07202728 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Treatment options for hydatidiform mole with lung nodules

    This study is testing different treatment options for patients with hydatidiform mole and lung nodules to see which approach works best for getting their hormone levels back to normal.

    Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT03785574

  • National reference center for gestational trophoblastic disease in France

    This study is about a special center in France that helps women with gestational trophoblastic disease by providing treatment and support while allowing them to stay connected with their local doctors.

    Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT02892877

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.