A Cohort Study of Hydatidiform Mole

Not yet recruiting

• Conditions: Hydatidiform Mole

• Registration Number: NCT05637892
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-23
• Status Verified: 2022-12
• Study Start: 2022-12-01
• Last Update Submitted: 2022-12-05
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-08
• Primary Completion: 2026-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignant trophoblastic tumor	4.5 years	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.