A Cohort Study of Hydatidiform Mole

N/ANot Yet RecruitingNCT05637892

Women's Hospital School Of Medicine Zhejiang University800 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Hydatidiform Mole

Interventions

No interventionOTHER

This is a prospective observational study with no intervention

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4.5 years

Central Contacts

Weiguo Lv, PhD

CONTACT

13588819218 lbwg@zju.edu.cn

Xiao Li, PhD

CONTACT

13958160137 5198009@zju.edu.cn

Data from ClinicalTrials.gov

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