A Cohort Study of Hydatidiform Mole | Clinical Trial

Key information

Conditions

Hydatidiform Mole Female Urogenital Diseases and Pregnancy Complications Gestational Trophoblastic Disease Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Pregnancy Complications Pregnancy Complications, Neoplastic Trophoblastic Neoplasms Urogenital Diseases

Age range

13 year–55 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
Age 13-55 years old;
Obtain informed consent and sign an informed consent form

Exclusion criteria

Patients who are unable to cooperate with the investigation such as mental disorders or cognitive impairment
No histopathology diagnosis;
Patients with other malignancies

Treatment and study plan

No intervention

Other

This is a prospective observational study with no intervention

Primary outcomes

Malignant trophoblastic tumor

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weiguo Lv, PhD

CONTACT

[email protected]

13588819218

Xiao Li, PhD

CONTACT

[email protected]

13958160137

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study title

A Multi-center Cohort Study of Hydatidiform Mole

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Dec 6, 2022
Registry last updated: Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting