Uterine FibroidNCT06234670
Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids
An observational study of Uterine Fibroid and Recurrence, run by Wenwen Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid, Recurrence
- What is being tested?
- No intervertion
- How many people
- 3,200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients with uterine fibroids and accept myomectomy.
Who may be able to join
- Age:18-50 years
- Diagnosed with uterine fibroids （by ultrasound or pathology）
- Accept myomectomy.
- Complete clinical data.
Who cannot join
- Severe infectious disease
- Previous history of malignant tumors
- Incomplete clinical data.
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Shixuan Wang
Wuhan, None Selected, 430030
shixuan Wang, 86-27-83663078, shixuanwang@tjh.tjmu.edu.cn
About this study
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.
Read the detailed description
Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.
According to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.
Recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.
- Conditions
- Uterine Fibroid, Recurrence
- Being tested
- No intervertion
- Keywords
- Uterine Fibroid, Recurrence, Risk factor, Prediction medel
- Medical subject headings
- Leiomyoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervertionOther
This study is a retrospective observational study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with uterine fibroids accepted myomectomy. | Complete the observation and follow-up, to identify the outcome （recur or not recur). Receives: Other: No intervertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, about June.2025
Secondary outcomes (6)
Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis
To identify the risk factors of recurrent uterine fibroids. We identify the risk factors through statistic analysis. Statistical significance proves to be the symbol of identifycation of risk factors.
Measured: about June.2024
The recurrence rate of uterine fibroids yearly
To calculate the recurrence rate of uterine fibroids yearly
Measured: about Febrary.2024
The fertility rate after myomectomy
To research the fertility rate after myomectomy and evaluate the impact of the surgery.
Measured: 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)
To assess the quality of life after myomectomy, we use UFS-QOL.The UFS-QOL, the most popular self-administered instrument in assessing the whole spectrum of fibroid-related symptoms and health-related quality of life among patients with uterine fibroids, was designed in 2002s by James B et.al.
Consisting of eight symptom items and twenty-nine health-related quality of life (HRQL) items of six subscales (concern, activities, energy/mood, control, self-consciousness, and sexual functioning), UFS-QOL is scored with a 5-point scale which demonstrates the patient' state of past 3 months. The final score (range, 0-100) is transformed based on a specific formula. Usually, a higher symptom severity score means more severe symptoms while a higher HRQL score indicates more perfect health
Measured: through study completion, about June.2025
The degree of abdominal pain after myomectomy will be assessed by VAS（visual analogue scale, VAS）
VAS is the most commonly used one-dimensional measure of pain intensity. The scale consists mainly of a 100 mm straight line with one end indicating "completely painless" and the other end indicating "the most severe pain imaginable" or "extremely painful", etc. Patients will be asked to mark the line at the appropriate location to represent the intensity of the pain they are experiencing at the time
Measured: through study completion, about June.2025
The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)
The Pictorial Blood Loss Assessment Chart (PBLAC) proposed by Higham JM in 1990 is widely used internationally to evaluate menstrual flow. 1 Menstrual blood loss chart The menstrual blood loss chart is given different scores according to the different degrees of blood staining of each sanitary napkin: mild (1 point), the blood stained area < 1/3 of the whole sanitary napkin; Moderate (5 points): The blood stained area accounts for 1/3~3/5 of the whole sanitary napkin; Severe (20 points): The blood-stained area is basically the entire sanitary napkin.
Measured: through study completion, about June.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenwen Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital
- Responsible party
- Sponsor-investigator, Wenwen Wang, Tongji Hospital
- Investigators
- Shixuan Wang, Phd, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234670
- Sponsor's protocol ID
- V1.0
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and A Prediction Model of Recurrence of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT06234670
- Acronym / sponsor ID
- V1.0
- Conditions
- Uterine Fibroid, Recurrence
- Keywords
- Uterine Fibroid, Recurrence, Risk factor, Prediction medel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Wenwen WangUniversity, hospital or other
- Collaborators
- Tongji Hospital
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Uterine fibroids are the most common benign tumors of female reproductive organs during childbearing age. With the emphasis on fertility preservation and the pursuit of the physical integrity, about 46% of patients prefer the conservative surgery which preserves the uterus. However, the high recurrence rate of uterine fibroids after conservative surgery does cause formidable clinical problems.
According to the literature, the recurrence rate is about 11.7% at one year after myomectomy and would increase steadily. At the eighth year of myomectomy, the recurrence rate is as high as 84.4%. During the long-term follow-up, about one-third of patients eventually require reoperation.
Recurrence not only leads to the recurrence of fibroid-related symptoms such as anemia, abdominal and pelvic pain, frequent urination and urgency, abnormal stool, etc., but also increases the burden of economic and national medical insurance, besides, it even causes serious problems such as psychological disorders, infertility, adverse pregnancy outcomes and malignant transformation, which affecting physical and mental health as well as destroying family happiness and threatening national population security.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with uterine fibroids accepted myomectomy. | – | Other: No intervertionComplete the observation and follow-up, to identify the outcome （recur or not recur). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients with uterine fibroids and accept myomectomy.
Key inclusion criteria (4 listed)
- Age:18-50 years
- Diagnosed with uterine fibroids （by ultrasound or pathology）
- Accept myomectomy.
- Complete clinical data.
Key exclusion criteria (4 listed)
- Severe infectious disease
- Previous history of malignant tumors
- Incomplete clinical data.
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervertionThis study is a retrospective observational study without intervention. | Other | Patients with uterine fibroids accepted myomectomy. |
Primary outcome
The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC
Time frame: through study completion, about June.2025
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)
6 secondary outcomes
Numbers of risk factors of recurrent uterine fibroids as certained by statistic analysis
Time frame: about June.2024
The recurrence rate of uterine fibroids yearly
Time frame: about Febrary.2024
The fertility rate after myomectomy
Time frame: 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)
Time frame: through study completion, about June.2025
The degree of abdominal pain after myomectomy will be assessed by VAS（visual analogue scale, VAS）
Time frame: through study completion, about June.2025
The blood loss will be assessed by PBLAC (Pictorial Blood Loss Assessment Chart (PBLAC)
Time frame: through study completion, about June.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shixuan Wang, Phd study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid and Recurrence, run by Wenwen Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shixuan Wang, Phd (86-27-83663078, shixuanwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of the prediction model for recurrence of uterine fibroids as assessed by AUC (time frame: through study completion, about June.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.