A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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

Qualifiers

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 (pGTN) during follow-up.

Disqualifiers

Missing clinical data.

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.

Concomitant malignancies or autoimmune deficiency disorders (e.g., systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).

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.

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

1,489 Participants
are divided into 1 treatment group

Sponsors and collaborators

Obstetrics & Gynecology Hospital of Fudan University

Lead sponsor

Peking Union Medical College Hospital

Collaborator

Shengjing Hospital

Collaborator

Hebei Medical University Third Hospital

Collaborator

Hainan women and children medical center

Collaborator

Shenzhen Maternity & Child Healthcare Hospital

Collaborator

Third Affiliated Hospital of Zhengzhou University

Collaborator

Shanghai First Maternity and Infant Hospital

Collaborator

International Peace Maternity and Child Health Hospital

Collaborator

Shandong University

Collaborator

First Affiliated Hospital of Zhejiang University

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Gansu Provincial Maternity and Child-care Hospital/Gansu Provincial Central Hospital

Collaborator

Dalian women and children's medical group

Collaborator