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Not yet recruitingNCT05637892Updated Dec 8, 2022

A Cohort Study of Hydatidiform Mole

An observational study in Hydatidiform Mole, sponsored by Women's Hospital School Of Medicine Zhejiang University. Not yet recruiting. Open to female participants aged 13 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
13 Years to 55 Years
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Hydatidiform Mole
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Who can participate

Ages eligible
13 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    This is a prospective observational study with no intervention

05

What researchers measure

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.

    Time frame: 4.5 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05637892
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Sponsor
First posted
Dec 6, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Dec 8, 2022

Study contacts

Weiguo Lv, PhD
Contact
lbwg@zju.edu.cn
13588819218
Xiao Li, PhD
Contact
5198009@zju.edu.cn
13958160137
Weiguo Lv, PhD
principal investigator · Women's Hospital School Of Medicine Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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