Uterine FibroidNCT05840042
Epidemiology and Risk Factors of Uterine Fibroids in China
An observational study of Uterine Fibroid, run by Wenwen Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
MINLI ZHANG, MASTER contact
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Shixuan Wang, PhD, 86-27-83663078, shixuanwang@tjh.tjmu.edu.cn
About this study
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.
- Conditions
- Uterine Fibroid
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of uterine fibroids in China
Prevalence of uterine fibroids in China
Measured: Baseline
Secondary outcomes (2)
Incidence of uterine fibroids in China
Incidence of uterine fibroids in China
Measured: Two follow-ups over a three-year period
Risk factors of development of uterine fibroids in China
Associated risk factors for recurrence, infertility and malignancy of uterine fibroids in China
Measured: Two follow-ups over a three-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenwen Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, The Fourth Hospital of Shijiazhuang
- Responsible party
- Sponsor-investigator, Wenwen Wang, Tongji Hospital
- Investigators
- SHIXUAN WANG, DOCTOR, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840042
- Sponsor's protocol ID
- V2.0
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38233053