Hydatidiform MoleCN-HM-01NCT07202728
A Multi-center Cohort Study of Hydatidiform Mole in China (CN-HM-01)
An observational study of Hydatidiform Mole, run by Obstetrics & Gynecology Hospital of Fudan University at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hydatidiform Mole
- How many people
- 1,489 participants
- Where
- 14 sitesChina
- Study dates
- 9 Jul 2025to 30 Aug 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Mingliang Ji, MD & PhD, +86-13426014593, julien8826@qq.com
Mingliang Ji, MD & PhD
- Not yet recruiting
Dalian Women and Children medical Center
Dalian, Liaoning, 116038
Lanzhou Jiao, MD & PhD, +86-18098858942, 2484440307@qq.com
Lanzhou Jiao, MD & PhD
- Recruiting
Hainan women and children medical center
Haikou, Hainan, 570311
Xiaoli Wang, MD & PhD, +86-17789839755, sfywxl@163.com
Xiaoli Wang, MD & PhD
- Not yet recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Yating Zhao, MD & PhD, +86-15268123511, zythrilled@163.com
Jianhua Qian, MD & PhD
- Not yet recruiting
Center for Reproductive Medicine, Shandong University
Jinan, Shandong, 250021
Ruijie Yu, MD & PhD, +86-18924197302, ridge_yu@126.com
Rusong Zhao, MD & PhD
- Recruiting
Gansu Province Maternal and Child Care Hospital
Lanzhou, Gansu, 730050
Shanshan Shi, MD & PhD, +86-0931-5188888, 410918535@qq.com
Chongli Guan, MD & PhD
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yan Kong, MD & PhD, +86-18661806925, 510534763@qq.com
Yanci Che, MD & PhD
- Not yet recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shandong, 201204
Na Liu, MD & PhD, +86-1517693296, 1517693296@qq.com
Xiaoqing Guo, MD & PhD
- Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
Yan Du, DrPH, +86-021-33189900, duyan7318@fckyy.org.cn
Hua Jiang, PhD & MD
- Not yet recruiting
International Peace Maternity and Child Health Hospital
Shanghai, 200030
Xiaoming Yang, MD & PhD, +86-19121942156, yangxiaoming516@126.com
Jiangjing Yuan, MD & PhD
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Fanfei Kong, MD & PhD, +86-13998385873, 13998385873@126.com
Xiaoxin Ma, MD & PhD
- Not yet recruiting
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, 518028
Qiuxia Li, MD & PhD, +86-18898830864, lz141019@163.com
Ping Jin, MD & PhD
- Not yet recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Yun Bai, MD & PhD, +86-15632189616, baiyun641113@163.com
Jun Liang, MD & PhD
- Not yet recruiting
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yanxiao Yu, MD & PhD, +86-15286836532, 15286836532@163.com
Chenchen Ren, MD & PhD
About this study
Official title: 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)
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
- Hydatidiform Mole
- Being tested
- No intervention
- Keywords
- Hydatidiform Mole, Observational Study
- Medical subject headings
- Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant transformation of hydatidiform mole
Diagnosed with pGTN according to the FIGO guideline diagnostic criteria
Measured: 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
Secondary outcomes (3)
Fertility outcomes
Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy.
Measured: 1 year and 2 year
Hospital Anxiety and Depression Scale (HADS)
ordinal scale, range: 0-3, higher scores means a worse outcome
Measured: Pathological diagnosis, 3 months after uterine evacuation
Reproductive Concerns After Cancer (RCAC)
ordinal scale, range: 1-5, higher scores mean a better outcome
Measured: Pathological diagnosis, 3 months after uterine evacuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start9 Jul 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatidiform MoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,489 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- 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 Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center
- Responsible party
- Principal investigator, Xin Lu, Obstetrics & Gynecology Hospital of Fudan University
- Investigators
- Xin Lu, MD & PhD, Study chair, Obstetrics & Gynecology Hospital of Fudan UniversityYang Xiang, MD & PhD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202728
- Sponsor's protocol ID
- 2025-109
- Acronym
- CN-HM-01
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07202728
- Acronym / sponsor ID
- CN-HM-01 / 2025-109
- Conditions
- Hydatidiform Mole
- Keywords
- Hydatidiform Mole, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,489 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- 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 Maternal and Child Health Care Hospital, Dalian Women and Children's Medical Center
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydatidiform mole | – | Other: No interventionThis cohort aims to support the development of evidence-based precision management strategies and facilitate nationwide promotion of optimal care practices for molar pregnancy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Hydatidiform mole |
Primary outcome
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
3 secondary outcomes
Fertility outcomes
Time frame: 1 year and 2 year
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pathological diagnosis, 3 months after uterine evacuation
Reproductive Concerns After Cancer (RCAC)
Time frame: Pathological diagnosis, 3 months after uterine evacuation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Hydatidiform Mole
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Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasia
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A Cohort Study of Hydatidiform Mole
Hydatidiform Mole
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The French National Reference Centre of GTD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Lu, MD & PhD study chair
Obstetrics & Gynecology Hospital of Fudan University
Yang Xiang, MD & PhD study chair
Peking Union Medical College Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydatidiform Mole, run by Obstetrics & Gynecology Hospital of Fudan University at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Lu, MD & PhD (+86-021-33189900, xin_lu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.