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
This trial does not accept healthy volunteersQualifiers
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 population
This study will enrol women with a confirmed hydatidiform mole who have undergone uterine evacuation. Candidates must possess complete clinical and pathological records and show no myometrial invasion or distant metastasis at baseline. We will exclude those with concurrent malignancy, severe autoimmune or infectious disease, or significant psychiatric illness. Longitudinal follow-up will track malignant transformation (post-molar gestational trophoblastic neoplasia per FIGO criteria), reproductive outcomes, and health-related quality of life. By establishing a large, nationwide, multicentre cohort, we aim to clarify the epidemiology, pinpoint risk factors for malignant progression, and evaluate long-term reproductive and psychosocial outcomes in this population.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
Malignant transformation of hydatidiform mole
Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
Secondary outcomes
Fertility outcomes
Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy.
Hospital Anxiety and Depression Scale (HADS)
ordinal scale, range: 0-3, higher scores means a worse outcome
Reproductive Concerns After Cancer (RCAC)
ordinal scale, range: 1-5, higher scores mean a better outcome
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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