A Cohort Study of Hydatidiform Mole

A Multi-center Cohort Study of Hydatidiform Mole

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hydatidiform Mole
• Intervention / Treatment: Other: No intervention

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Weiguo Lv, PhD; Phone Number: 13588819218; Email: lbwg@zju.edu.cn
• Study Contact Backup: Name: Xiao Li, PhD; Phone Number: 13958160137; Email: 5198009@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Outpatient or inpatient patients in women's hospital school medicine of zhejiang university and other cooperative hospitals (including tongji hosptial, tongji medical college of hust, qilu hosptial of shandong university, Sun Yat-sen university cancer center) were inclued in this cohort study if the patients met the eligibility requirements and agreed to participate in this study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Weiguo Lv, PhD, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Gestational Trophoblastic Disease; Hydatidiform Mole
• Other Study ID Numbers: IRB-20220312-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No