ClinicalTrials.gg
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
03

In context

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

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

06

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for Dec 2026, 48 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2022
First posted
Dec 6, 2022
StartEst.
Dec 1, 2022
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jun 1, 2027
Last update
Dec 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion