A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)

NCT ID: NCT07202728

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-09

Study Completion Date

2030-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hydatidiform Mole

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Hainan women and children medical center

UNKNOWN

Sponsor Role collaborator

Shenzhen Maternity & Child Healthcare Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Gansu Provincial Maternity and Child-care Hospital/Gansu Provincial Central Hospital

UNKNOWN

Sponsor Role collaborator

Dalian women and children's medical group

UNKNOWN

Sponsor Role collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xin Lu

Director of Chemotherapy Unit, Gynecologic Oncology Department, Obstetrics and Gynecology Hospital,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Lu, MD & PhD

Role: STUDY_CHAIR

Obstetrics & Gynecology Hospital of Fudan University

Yang Xiang, MD & PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Gansu Province Maternal and Child Care Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Hainan women and children medical center

Haikou, Hainan, China

Site Status RECRUITING

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Site Status NOT_YET_RECRUITING

Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Dalian Women and Children medical Center

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Center for Reproductive Medicine, Shandong University

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status NOT_YET_RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shandong, China

Site Status NOT_YET_RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

International Peace Maternity and Child Health Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xin Lu, MD & PhD

Role: CONTACT

+86-021-33189900

Yan Du, DrPH

Role: CONTACT

+86-021-33189900

Facility Contacts

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Shanshan Shi, MD & PhD

Role: primary

+86-0931-5188888

Qiuxia Li, MD & PhD

Role: primary

+86-18898830864

Xiaoli Wang, MD & PhD

Role: primary

+86-17789839755

Yun Bai, MD & PhD

Role: primary

+86-15632189616

Yanxiao Yu, MD & PhD

Role: primary

+86-15286836532

Lanzhou Jiao, MD & PhD

Role: primary

+86-18098858942

Fanfei Kong, MD & PhD

Role: primary

+86-13998385873

Ruijie Yu, MD & PhD

Role: primary

+86-18924197302

Yan Kong, MD & PhD

Role: primary

+86-18661806925

Na Liu, MD & PhD

Role: primary

+86-1517693296

Yan Du, DrPH

Role: primary

+86-021-33189900

Yating Zhao, MD & PhD

Role: primary

+86-15268123511

Mingliang Ji, MD & PhD

Role: primary

+86-13426014593

Xiaoming Yang, MD & PhD

Role: primary

+86-19121942156

Other Identifiers

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2025-109

Identifier Type: -

Identifier Source: org_study_id

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