A Cohort Study of Hydatidiform Mole

Hydatidiform Mole Clinical Trial

Official title:

A Multi-center Cohort Study of Hydatidiform Mole

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637892
• Other study ID #: IRB-20220312-R
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: June 1, 2027

Study information

• Verified date: December 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Weiguo Lv, PhD
• Phone: 13588819218
• Email: lbwg[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to construct a cohort for the hydatidiform mole.

Description:

After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: June 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients who are diagnosed with hydatidiform mole (including: complete hydatidiform mole/partial hydatidiform mole; one of twins with hydatidiform mole; ectopic pregnancy hydatidiform mole; macroscopic or microscopic hydatidiform changes indicating early complete or partial hydatidiform mole can not be excluded; atypical placental site nodule) for the first time;

2. Age 13-55 years old;

3. Obtain informed consent and sign an informed consent form

Exclusion Criteria:

1. Patients who are unable to cooperate with the investigation such as mental disorders or cognitive impairment

2. No histopathology diagnosis;

3. Patients with other malignancies

Related Conditions & MeSH terms

• Hydatidiform Mole

Intervention

Other:
• No intervention
This is a prospective observational study with no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignant trophoblastic tumor	Patients with hydatidiform mole develop malignant trophoblastic tumor. The Federation of International of Gynecologists and Obstetricians criteria for diagnosis of postmolar gestational trophoblastic neoplasia were as follows: (1) when the plateau of human chorionic gonadotrophin (hCG) lasts for four measurements over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; (2) when there is a rise in hCG for three consecutive weekly measurements over at least a period of 2 weeks or more; days 1, 7, 14; (3) If there is a histologic diagnosis of choriocarcinoma.	4.5 years