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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

1,489 Participants
are divided into 1 treatment group
Group A: Hydatidiform mole1 intervention

Trial outcomes

Primary outcomes

1

Malignant transformation of hydatidiform mole

Diagnosed with pGTN according to the FIGO guideline diagnostic criteria

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

Secondary outcomes

1

Fertility outcomes

Reproductive outcomes such as pregnancy rate, live birth rate, and miscarriage rate, following the uterine evacuation of the current molar pregnancy.

Time frame
1 year and 2 year
2

Hospital Anxiety and Depression Scale (HADS)

ordinal scale, range: 0-3, higher scores means a worse outcome

Time frame
Pathological diagnosis, 3 months after uterine evacuation
3

Reproductive Concerns After Cancer (RCAC)

ordinal scale, range: 1-5, higher scores mean a better outcome

Time frame
Pathological diagnosis, 3 months after uterine evacuation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Obstetrics & Gynecology Hospital of Fudan University

Lead sponsor

Peking Union Medical College Hospital

Collaborator

Shengjing Hospital

Collaborator

Hebei Medical University Third Hospital

Collaborator

Hainan women and children medical center

Collaborator

Shenzhen Maternity & Child Healthcare Hospital

Collaborator

Third Affiliated Hospital of Zhengzhou University

Collaborator

Shanghai First Maternity and Infant Hospital

Collaborator

International Peace Maternity and Child Health Hospital

Collaborator

Shandong University

Collaborator

First Affiliated Hospital of Zhejiang University

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

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

Collaborator

Dalian women and children's medical group

Collaborator