Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids

NCT06234670 | Unknown

• 1 other identifier: V1.0
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.

Conditions

Uterine Fibroid; Recurrence

Keywords

Uterine Fibroid; Recurrence; Risk factor; Prediction medel

Outcome Measures

Primary Outcomes (1)

• The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC

  Complete the follow-up, and compare the actual recurrence population with the predicted recurrence population to judge the performance of the prediction model. Use the AUC (Area Under Curve)

  through study completion, about June.2025

Secondary Outcomes (6)

• Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis

  about June.2024

• The recurrence rate of uterine fibroids yearly

  about Febrary.2024

• The fertility rate after myomectomy

  about Febrary.2024

• The quality of life after myomectomy will be assessed by UFS-QOL,(uterine fibroid symptom and health-related quality of life, UFS-QOL)

  through study completion, about June.2025

• The degree of abdominal pain after myomectomy will be assessed by VAS（visual analogue scale, VAS）

  through study completion, about June.2025

Study Arms (1)

Patients with uterine fibroids accepted myomectomy.

Complete the observation and follow-up, to identify the outcome （recur or not recur).

Other: No intervertion

Interventions

No intervertion OTHER

This study is a retrospective observational study without intervention.

Patients with uterine fibroids accepted myomectomy.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female patients with uterine fibroids
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female patients with uterine fibroids and accept myomectomy.

You may qualify if:

• Age:18-50 years
• Diagnosed with uterine fibroids （by ultrasound or pathology）
• Accept myomectomy.
• Complete clinical data.

You may not qualify if:

• Severe infectious disease
• Previous history of malignant tumors
• Incomplete clinical data.
• Pregnant

Sponsors & Collaborators

• Wenwen Wang: lead
• Tongji Hospital: collaborator

Study Sites (1)

Shixuan Wang

Wuhan, None Selected, 430030, China

Location

MeSH Terms

Conditions

Leiomyoma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shixuan Wang, Phd

  Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

shixuan Wang, Phd

CONTACT

86-27-83663078; shixuanwang@tjh.tjmu.edu.cn

Wenwen Wang, Phd

CONTACT

86-27-83663078; wenwenwang@hust.edu.cn

Study Design

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

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 31, 2024
• Study Start: January 25, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)