Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis)NCT05310318
Prognosis of Low-grade Endometrial Stromal Sarcoma
An observational study of Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis) and Fertility-sparing Surgery, run by Lei Li at 1 site in China.
Trial summary
This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis), Fertility-sparing Surgery, Survival Outcomes
- What is being tested?
- Surgical treatment with and without fertility-sparing procedures
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2022to 26 Mar 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients accepted surgical treatment with and without fertility-sparing procedures for uterine low-grade endometrial stromal sarcoma.
Who may be able to join
- Aged 18 years or older
- Confirmed of LGESS
- Acceptance of surgical treatment for LGESS
- With detailed follow-up outcomes
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Surgical and Reproductive Results of Fertility-sparing Treatment for Low-grade Endometrial Stromal Sarcoma: A Retrospective Cohort Study
This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.
- Conditions
- Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis), Fertility-sparing Surgery, Survival Outcomes, Fertility Outcomes, Recurrence, Hormone Therapy
- Being tested
- Surgical treatment with and without fertility-sparing procedures
- Medical subject headings
- Endometrial Stromal Tumors, Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment with and without fertility-sparing proceduresProcedure or surgery
Also called Adjuvant therapy after surgery
Patients accepted surgeries for LGESS and relevant adjuvant therapy if indicated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival after surgery
Measured: One year
Overall survival
Overall survival after surgery
Measured: One year
Pregnancy rate
Pregnancy rate after surgery in patients with fertility-sparing patients
Measured: One year
Secondary outcomes (2)
Miscarriage rate
Miscarriage rate after surgery in patients with fertility-sparing patients
Measured: One year
Full-term pregnancy rate
Full-term pregnancy rate after surgery in patients with fertility-sparing patients
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start26 Mar 2022
- Primary completion26 Mar 2024 (estimated)
- Study completion26 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310318
- Sponsor's protocol ID
- SOUM-2
- Status last verified
- Mar 2022
- First submitted
- 26 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Reproductive Results of Fertility-sparing Treatment for Low-grade Endometrial Stromal Sarcoma: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05310318
- Acronym / sponsor ID
- SOUM-2
- Conditions
- Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis), Fertility-sparing Surgery, Survival Outcomes, Fertility Outcomes, Recurrence, Hormone Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 26 Mar 2024 (estimated)
- Study completion
- 26 Mar 2025 (estimated)
- First posted
- 4 Apr 2022 (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.
This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients accepted surgical treatment with and without fertility-sparing procedures for uterine low-grade endometrial stromal sarcoma.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Confirmed of LGESS
- Acceptance of surgical treatment for LGESS
- With detailed follow-up outcomes
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| Surgical treatment with and without fertility-sparing proceduresAlso: Adjuvant therapy after surgeryPatients accepted surgeries for LGESS and relevant adjuvant therapy if indicated. | Procedure or surgery | – |
Primary outcome
Progression-free survival
Time frame: One year
Progression-free survival after surgery
Overall survival
Time frame: One year
Overall survival after surgery
Pregnancy rate
Time frame: One year
Pregnancy rate after surgery in patients with fertility-sparing patients
2 secondary outcomes
Miscarriage rate
Time frame: One year
Full-term pregnancy rate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
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 Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis) and Fertility-sparing Surgery, run by Lei Li 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 1 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 4 Apr 2022. 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 Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: One year). The study lists 3 primary outcomes in all. 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 4 Apr 2022.