A Cohort Study of Uterine Malignancies | NCT05635123

Studies
A Cohort Study of Uterine Malignancies

NCT05635123

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Status

Recruiting

Last Update Posted

Jul 17, 2025Actual

Enrollment

6,200Estimated

Phase

Not provided

Conditions

Cervical Cancer
Endometrial Cancer

Interventions

No intervention

Countries

China

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2030Estimated

First Submitted Date

Nov 22, 2022

First Submission Date that Met QC Criteria

Nov 22, 2022

First Posted Date

Dec 2, 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

Jul 14, 2025

Last Update Posted Date

Jul 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of current study were to explore the relationship between cervical cancer/endometrial cancer and demographic information, behavior and life style, pregnancy-related factors, and disease history, and to study the factors affecting the prognosis of cancers. In addition, omics tests were performed on the biological specimens to identify the diagnostic markers and prognostic biomarkers.

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

6,200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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
progression free survival (PFS)	progression free survival for patients with cervical cancer or endometrial cancer	60 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-75 years;
Women with cervical cancer or endometrial cancer with a definite pathological diagnosis for the first time;
Women attending a health check-up;
Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

Patients who are unable to cooperate with the investigations such as mental disorders or cognitive impairment；
Patients with cancer other than cervical cancer or endometrial cancer;
Women who have received hysterectomy or pelvic radiation therapy previously.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The investigators establish a population cohort of 6200 women including patients with cervical cancer or endometrial cancer, and women attending to a health check-up.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hui Wang, PhD	Contact	0571-89998857		wang71hui@zju.deu.cn
Xiao Li, PhD	Contact	13958160137		5198009@zju.edu.cn

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's hospital school of medicine zhejiang university	Recruiting	Hangzhou	Zhejiang	310000	China

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
D002583	Uterine Cervical Neoplasms
D016889	Endometrial Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided