Endometrial CancerTREE PRONCT04227249
3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer
An observational study of Endometrial Cancer, run by Seoul National University Hospital.
Trial summary
To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- no lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- Adult, Older adult
Study population: endometrial cancer with ultra-low risk for lymph node metastasis
Who may be able to join
- endometrioid type
- anticipated surgery omitting lymph node dissection for endometrial cancer
- pelvis MRI, CA125 - satisfying KGOG criteria
- no distant metastasis
- age 19 or more
Who cannot join
- other cancer within 5 yr
- previous hysterectomy
- previous therapy for endometrial cancer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction
To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection
- Conditions
- Endometrial Cancer
- Being tested
- no lymph node dissection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no lymph node dissectionProcedure or surgery
do not undergo lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Experimental | women who do not undergo lymph node dissection Receives: Procedure: no lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year recurrence free survival
3 year recurrence free survival
Measured: 3 year since surgery
Secondary outcomes (10)
5 year recurrence free survival
5 year recurrence free survival
Measured: 5 year since surgery
5 year overall survival
5 year overall survival
Measured: 5 year since surgery
surgery time
from surgery start to end
Measured: surgery visit
change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline
functional assessment of cancer therapy - general
Measured: baseline - 1week - 5week - 3month - 6month
change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline
gynecologic cancer lymphedema questionnaire - Korean
Measured: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
change of Female Sexual Function Index (FSFI) score from baseline
female sexual function index
Measured: baseline - 6month - 12month - 24month - 36month - 48month - 60month
length of stay
from admission to discharge
Measured: surgery visit
transfusion
amount of transfusion
Measured: surgery visit
hemoglobin decline
change of hemoglobin level from baseline to postoperative lowest level
Measured: surgery visit
surgery complication
any surgery complications observed
Measured: surgery visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startApr 2020 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227249
- Sponsor's protocol ID
- KGOG 3021
- Acronym
- TREE PRO
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2020
- Last updated
- 14 Jan 2020
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction
- ClinicalTrials.gov ID
- NCT04227249
- Acronym / sponsor ID
- TREE PRO / KGOG 3021
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jan 2020 (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 verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Procedure: no lymph node dissectionwomen who do not undergo lymph node dissection |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- endometrial cancer with ultra-low risk for lymph node metastasis
Key inclusion criteria (5 listed)
- endometrioid type
- anticipated surgery omitting lymph node dissection for endometrial cancer
- pelvis MRI, CA125 - satisfying KGOG criteria
- no distant metastasis
- age 19 or more
Key exclusion criteria (3 listed)
- other cancer within 5 yr
- previous hysterectomy
- previous therapy for endometrial cancer
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 lymph node dissectiondo not undergo lymph node dissection | Procedure or surgery | Experimental |
Primary outcome
3 year recurrence free survival
Time frame: 3 year since surgery
3 year recurrence free survival
10 secondary outcomes
5 year recurrence free survival
Time frame: 5 year since surgery
5 year overall survival
Time frame: 5 year since surgery
surgery time
Time frame: surgery visit
change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline
Time frame: baseline - 1week - 5week - 3month - 6month
change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline
Time frame: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
change of Female Sexual Function Index (FSFI) score from baseline
Time frame: baseline - 6month - 12month - 24month - 36month - 48month - 60month
length of stay
Time frame: surgery visit
transfusion
Time frame: surgery visit
hemoglobin decline
Time frame: surgery visit
surgery complication
Time frame: surgery visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Seoul National University Hospital.
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 5 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: opening soon, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kidong kim, md (82 31 787 7262, kidong.kim.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year recurrence free survival (time frame: 3 year since surgery). 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 14 Jan 2020.