A Cohort Study of Hydatidiform Mole

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05637892
Collaborator
(none)
800
54

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-center Cohort Study of Hydatidiform Mole
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Jun 1, 2027

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT05637892
Other Study ID Numbers:
  • IRB-20220312-R
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022