Clinical trial · Observational
A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
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)
NCT07202728CI-TRIAL-00096150CN-HM-01recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hydatidiform Mole | Molar Pregnancy | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hydatidiform mole
- description
- This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Malignant transformation of hydatidiform mole
- timeFrame
- 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
- description
- Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
Secondary outcomes (3)
- measure
- Fertility outcomes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.