A Cohort Study of Hydatidiform Mole | NCT05637892

Studies
A Cohort Study of Hydatidiform Mole

NCT05637892

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Status

Not yet recruiting

Last Update Posted

Dec 8, 2022Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Hydatidiform Mole

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 23, 2022

First Posted Date

Dec 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2022

Last Update Posted Date

Dec 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	This is a prospective observational study with no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weiguo Lv, PhD	Contact	13588819218		lbwg@zju.edu.cn
Xiao Li, PhD	Contact	13958160137		5198009@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Weiguo Lv, PhD	Women's Hospital School Of Medicine Zhejiang University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006828	Hydatidiform Mole

Ancestor Terms

ID	Term
D031901	Gestational Trophoblastic Disease
D014328	Trophoblastic Neoplasms
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

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Browse Branches

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