Endometrial NeoplasmsNCT03291275
Survival Outcomes of Uterine Malignancies in Chinese Population
An observational study of Endometrial Neoplasms and Survival, run by Lei Li at 1 site in China.
Trial summary
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Neoplasms, Survival
- What is being tested?
- Follow-up for death and recurrence
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Sep 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with definite diagnosis of uterine malignancies in China.
Who may be able to join
- Primary uterine malignancies.
Who cannot join
- Metastatic malignancies to uterine corpus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, China/Beiing, 100000
Lei L Li, MD, 13911988831 ext. +86, lileigh@163.com
About this study
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study.
- Conditions
- Endometrial Neoplasms, Survival
- Being tested
- Follow-up for death and recurrence
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up for death and recurrenceOther
All patients are followed up to determine definite date of diagnosis, recurrence and death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival duration from diagnosis to death
Measured: 5 years
Progression-free survival
Survival duration from last treatment after remission to recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (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 Endometrial NeoplasmsStudies 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
- 10,000 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, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291275
- Sponsor's protocol ID
- SOUM-1
- Status last verified
- Feb 2018
- First submitted
- 20 Sep 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li L, Ma SQ, Tan XJ, Zhong S, Wu M. Pelvic Exenteration for Recurrent and Persistent Cervical Cancer. Chin Med J (Engl). 2018 Jul 5;131(13):1541-1548. doi: 10.4103/0366-6999.235111.
PubMed 29941707
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes of Uterine Malignancies in Chinese Population
- ClinicalTrials.gov ID
- NCT03291275
- Acronym / sponsor ID
- SOUM-1
- Conditions
- Endometrial Neoplasms, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Sep 2017 (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 aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with definite diagnosis of uterine malignancies in China.
Key inclusion criteria (1 listed)
- Primary uterine malignancies.
Key exclusion criteria (1 listed)
- Metastatic malignancies to uterine corpus
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 |
|---|---|---|
| Follow-up for death and recurrenceAll patients are followed up to determine definite date of diagnosis, recurrence and death. | Other | – |
Primary outcome
Overall survival
Time frame: 5 years
Survival duration from diagnosis to death
Progression-free survival
Time frame: 5 years
Survival duration from last treatment after remission to recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 29941707Li L, Ma SQ, Tan XJ, Zhong S, Wu M. Pelvic Exenteration for Recurrent and Persistent Cervical Cancer. Chin Med J (Engl). 2018 Jul 5;131(13):1541-1548. doi: 10.4103/0366-6999.235111.
- Individual participant dataSharing planned: No
Related trials for Endometrial Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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, MD 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 Endometrial Neoplasms and Survival, 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 1 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 8 Feb 2018. 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, MD (13911988831 ext. +86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03291275, which also lists 1 linked publication.
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 8 Feb 2018.