A Cohort Study of Hydatidiform Mole

NCT05637892 | Not Yet Recruiting

• 1 other identifier: IRB-20220312-R
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hydatidiform Mole

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

No intervention OTHER

This is a prospective observational study with no intervention

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Collect blood, and tissue samples from patients

MeSH Terms

Conditions

Hydatidiform Mole

Condition Hierarchy (Ancestors)

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

Study Officials

• Weiguo Lv, PhD

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiguo Lv, PhD

CONTACT

13588819218; lbwg@zju.edu.cn

Xiao Li, PhD

CONTACT

13958160137; 5198009@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 6, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share