Uterine SarcomaNCT05881967
Molecular Mechanism Study of Uterine Sarcoma
An observational study of Uterine Sarcoma, run by Shixuan Wang at 1 site in China.
Trial summary
The purpose of this project was to use multi-omics technology to screen the key factors for the occurrence and development of uterine sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Uterine Sarcoma
- What is being tested?
- Diagnostic biomarker
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Nov 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 400 patients who met the requirements includ 200 uterine sarcomas, 200 uterine leiomyomas.
Who may be able to join
- Age 18 or older;
- Newly treated or recurenced uterine sarcoma.
Who cannot join
- Diagnosis of other malignancies within the past 5 years;
- history of pelvic or vaginal radiation therapy;
- Known high-grade lesions of the cervix and endometrium.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yan Li
Wuhan, Hubei, 430030
Yan Li, Dr, 13971026069, liyan@tjh.tjmu.edu.cn
About this study
The purpose of this project was to use multi-omics technology to screen the key factors for the occurrence and development of uterine sarcoma.
Read the detailed description
Uterine sarcomas are rare mesenchymal neoplasms in the female genital system, accounting for about 1% of female reproductive tract malignancies and 3%~7% of uterine malignancies. Subtypes of uterine sarcoma are leiomyosarcoma, endometrial stromal sarcoma, and adenosarcoma. Uterine leiomyosarcoma is the most common uterine sarcoma, accounting for about 1% to 2% of all uterine malignancies.
Uterine sarcomas differ in histologic appearance and clinical behavior. The incidence of uterine sarcoma is low and the prognosis is poor. Its manifestations mainly include abnormal vaginal bleeding, abdominal pain and abdominal mass, but none of these symptoms are specific.
For uterine sarcoma, there are no diagnostic serum markers and imaging features and the diagnosis of uterine sarcoma still mainly depends on postoperative pathological results. However, with the development of omics technology, immunophenotypes and molecular characterization of uterine sarcomas have increasingly been utilized to improve diagnostic classification and prognostication in uterine sarcomas. Uterine leiomyosarcoma, the most common subtype of uterine sarcoma, does not have a single defining molecular abnormality.
This project intends to use multi-omics technology to screen the key factors for the occurrence, development, and malignant transformation of uterine sarcoma, especially uterine leiomyosarcoma, and to map the interaction network of cell signaling pathways. It provides key molecular markers for the early assessment of recurrence and malignant transformation of uterine myoma after conservative treatment, and provides a molecular mechanism basis for finding solutions to prevent the progression and malignant transformation.
- Conditions
- Uterine Sarcoma
- Being tested
- Diagnostic biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic biomarkerDiagnostic test
Diagnostic gene for uterine sarcoma
| Study group | Role | What they receive |
|---|---|---|
| Uterine sarcoma | Participants were enrolled for the first treatment of uterine sarcoma or secondary operation for recurrence fo uterine sarcoma. Receives: Diagnostic Test: Diagnostic biomarker | |
| Uterine fibroid | Participants were enrolled for surgery of uterine fibroids. Receives: Diagnostic Test: Diagnostic biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptible gene in women with uterine sarcoma
Analyze genetic susceptibility among women exhibiting disease manifestations of uterine sarcoma
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Mar 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SarcomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shixuan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shixuan Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881967
- Sponsor's protocol ID
- IRB20221166
- Status last verified
- May 2023
- First submitted
- 21 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanism Study of Uterine Sarcoma
- ClinicalTrials.gov ID
- NCT05881967
- Acronym / sponsor ID
- IRB20221166
- Conditions
- Uterine Sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shixuan WangUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 31 May 2023 (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.
The purpose of this project was to use multi-omics technology to screen the key factors for the occurrence and development of uterine sarcoma.
Detailed description
Uterine sarcomas are rare mesenchymal neoplasms in the female genital system, accounting for about 1% of female reproductive tract malignancies and 3%~7% of uterine malignancies. Subtypes of uterine sarcoma are leiomyosarcoma, endometrial stromal sarcoma, and adenosarcoma. Uterine leiomyosarcoma is the most common uterine sarcoma, accounting for about 1% to 2% of all uterine malignancies.
Uterine sarcomas differ in histologic appearance and clinical behavior. The incidence of uterine sarcoma is low and the prognosis is poor. Its manifestations mainly include abnormal vaginal bleeding, abdominal pain and abdominal mass, but none of these symptoms are specific.
For uterine sarcoma, there are no diagnostic serum markers and imaging features and the diagnosis of uterine sarcoma still mainly depends on postoperative pathological results. However, with the development of omics technology, immunophenotypes and molecular characterization of uterine sarcomas have increasingly been utilized to improve diagnostic classification and prognostication in uterine sarcomas. Uterine leiomyosarcoma, the most common subtype of uterine sarcoma, does not have a single defining molecular abnormality.
This project intends to use multi-omics technology to screen the key factors for the occurrence, development, and malignant transformation of uterine sarcoma, especially uterine leiomyosarcoma, and to map the interaction network of cell signaling pathways. It provides key molecular markers for the early assessment of recurrence and malignant transformation of uterine myoma after conservative treatment, and provides a molecular mechanism basis for finding solutions to prevent the progression and malignant transformation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine sarcoma | – | Diagnostic Test: Diagnostic biomarkerParticipants were enrolled for the first treatment of uterine sarcoma or secondary operation for recurrence fo uterine sarcoma. |
| Uterine fibroid | – | Diagnostic Test: Diagnostic biomarkerParticipants were enrolled for surgery of uterine fibroids. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 patients who met the requirements includ 200 uterine sarcomas, 200 uterine leiomyomas.
Key inclusion criteria (2 listed)
- Age 18 or older;
- Newly treated or recurenced uterine sarcoma.
Key exclusion criteria (3 listed)
- Diagnosis of other malignancies within the past 5 years;
- history of pelvic or vaginal radiation therapy;
- Known high-grade lesions of the cervix and endometrium.
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 |
|---|---|---|
| Diagnostic biomarkerDiagnostic gene for uterine sarcoma | Diagnostic test | Uterine fibroid, Uterine sarcoma |
Primary outcome
Susceptible gene in women with uterine sarcoma
Time frame: baseline
Analyze genetic susceptibility among women exhibiting disease manifestations of uterine sarcoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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.
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 Sarcoma, run by Shixuan 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 2 inclusion and 3 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 May 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Susceptible gene in women with uterine sarcoma (time frame: baseline). 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 May 2023.