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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,489
- Locations
- 14
- Primary Endpoint
- Malignant transformation of hydatidiform mole
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •No history of psychiatric disorders, serious infectious diseases, or immune system diseases (such as systemic lupus erythematosus, myasthenia gravis, HIV infection, etc.).
- •Willing to participate in this study and sign the relevant informed consent form.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Malignant transformation of hydatidiform mole
Time Frame: 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 Outcomes
- Fertility outcomes(1 year and 2 year)
- Hospital Anxiety and Depression Scale (HADS)(Pathological diagnosis, 3 months after uterine evacuation)
- Reproductive Concerns After Cancer (RCAC)(Pathological diagnosis, 3 months after uterine evacuation)
Investigators
Xin Lu
Director of Chemotherapy Unit, Gynecologic Oncology Department, Obstetrics and Gynecology Hospital,
Obstetrics & Gynecology Hospital of Fudan University