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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Shengjing Hospital | OTHER |
| Hebei Medical University Third Hospital | OTHER |
| Hainan women and children medical center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydatidiform mole | This cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Malignant transformation of hydatidiform mole | Diagnosed with pGTN according to the FIGO guideline diagnostic criteria | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fertility outcomes | Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy. | 1 year and 2 year |
| Hospital Anxiety and Depression Scale (HADS) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Lu, MD & PhD | Contact | +86-021-33189900 | xin_lu@fudan.edu.cn | |
| Yan Du, DrPH | Contact | +86-021-33189900 | duyan7318@fckyy.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Lu, MD & PhD | Obstetrics & Gynecology Hospital of Fudan University | Study Chair |
| Yang Xiang, MD & PhD | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gansu Province Maternal and Child Care Hospital | Recruiting | Lanzhou | Gansu | 730050 | China |
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| ID | Term |
|---|---|
| D006828 | Hydatidiform Mole |
| ID | Term |
|---|---|
| D031901 | Gestational Trophoblastic Disease |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| UNKNOWN |
| Shenzhen Maternity & Child Healthcare Hospital | OTHER |
| Third Affiliated Hospital of Zhengzhou University | OTHER |
| Shanghai First Maternity and Infant Hospital | OTHER |
| International Peace Maternity and Child Health Hospital | OTHER |
| Shandong University | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Gansu Provincial Maternal and Child Health Care Hospital | OTHER |
| Dalian women and children's medical group | UNKNOWN |
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All samples are collected after obtaining informed consent, and stored under strict ethical guidelines.
ordinal scale, range: 0-3, higher scores means a worse outcome
| Pathological diagnosis, 3 months after uterine evacuation |
| Reproductive Concerns After Cancer (RCAC) | ordinal scale, range: 1-5, higher scores mean a better outcome | Pathological diagnosis, 3 months after uterine evacuation |
| Shenzhen Maternity & Child Healthcare Hospital | Not yet recruiting | Shenzhen | Guangdong | 518028 | China |
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| Hainan women and children medical center | Recruiting | Haikou | Hainan | 570311 | China |
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| Hebei Medical University Third Hospital | Not yet recruiting | Shijiazhuang | Hebei | 050051 | China |
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| Third Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Dalian Women and Children medical Center | Not yet recruiting | Dalian | Liaoning | 116038 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
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| Center for Reproductive Medicine, Shandong University | Not yet recruiting | Jinan | Shandong | 250021 | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266000 | China |
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| Shanghai First Maternity and Infant Hospital | Not yet recruiting | Shanghai | Shandong | 201204 | China |
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| Obstetrics & Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200090 | China |
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| First Affiliated Hospital of Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| International Peace Maternity and Child Health Hospital | Not yet recruiting | Shanghai | 200030 | China |
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| D009369 | Neoplasms |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |