NCT05840042

Brief Summary

Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.

Trial Health

65
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Trial Health Score

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Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

April 21, 2023

Last Update Submit

June 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of uterine fibroids in China

    Prevalence of uterine fibroids in China

    Baseline

Secondary Outcomes (2)

  • Incidence of uterine fibroids in China

    Two follow-ups over a three-year period

  • Risk factors of development of uterine fibroids in China

    Two follow-ups over a three-year period

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study population is women aged more than 18yrs with or without uterine fibroids from five regions of China. The study time period will conduct from May 1, 2023 - November 30, 2025 to allow for 6 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of one years follow-up.

You may qualify if:

  • Current place of residence≥ 6 months;
  • No serious mental illness or mental abnormality;
  • Those who agree to participate in this survey and cooperate in completing the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yan W, Yuan S, Zhou D, Zhang M, Yang S, Wang W, Wang S. Status and treatment of patients with uterine fibroids in hospitals in central China: a retrospective study from 2018 to 2021. BMJ Open. 2024 Jan 17;14(1):e081736. doi: 10.1136/bmjopen-2023-081736.

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • SHIXUAN WANG, DOCTOR

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WENWEN WANG, DOCTOR

CONTACT

MINLI ZHANG, MASTER

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

June 19, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

June 22, 2023

Record last verified: 2023-06