Hydatidiform Mole
Conditions
Keywords
Hydatidiform Mole, Observational Study
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Peking Union Medical College Hospital
Shengjing Hospital
Hebei Medical University Third Hospital
Hainan women and children medical center
Shenzhen Maternity & Child Healthcare Hospital
Third Affiliated Hospital of Zhengzhou University
Shanghai First Maternity and Infant Hospital
International Peace Maternity and Child Health Hospital
Shandong University
First Affiliated Hospital of Zhejiang University
The Affiliated Hospital of Qingdao University
Gansu Provincial Maternity and Child-care Hospital/Gansu Provincial Central Hospital
Dalian women and children's medical group
Obstetrics & Gynecology Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malignant transformation of hydatidiform mole | Postoperative b-hCG levels were monitored every 1-2 weeks. While patients with PHM could discontinue follow-up after b-hCG normalization, those with CHM- given their higher risk of malignant progression- require monthly monitoring for 6 months following | Diagnosed with pGTN according to the FIGO guideline diagnostic criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproductive Concerns After Cancer (RCAC) | Pathological diagnosis, 3 months after uterine evacuation | ordinal scale, range: 1-5, higher scores mean a better outcome |
| Fertility outcomes | 1 year and 2 year | 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) | Pathological diagnosis, 3 months after uterine evacuation | ordinal scale, range: 0-3, higher scores means a worse outcome |
Countries
China
Contacts
Primary ContactXin Lu, MD & PhD
Backup ContactYan Du, DrPH
Outcome results
None listed