Early Stage Endometrial CancerNCT05048173
Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer
An observational study of Early Stage Endometrial Cancer and Sentinel Lymph Nodes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Early Stage Endometrial Cancer, Sentinel Lymph Nodes, Lymphadenectomy
- What is being tested?
- Sentinel lymph node mapping and biopsy and Lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 334 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 2 Jun 2022
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 20 and above, diagnosed with early stage endometrial cancer (FIGO stage I), who had received staging surgery between 01 July 2017 and 19 August 2021 were included in the study.
Who may be able to join
- ≧ 20 years
- early stage endometrial cancer (FIGO stage I)
Who cannot join
- Did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early Stage Endometrial Cancer
To compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.
Read the detailed description
This retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.
- Being tested
- Sentinel lymph node mapping and biopsy, Lymphadenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node mapping and biopsyProcedure or surgery
Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive
LymphadenectomyProcedure or surgery
Conventional lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node group | woman who had sentinel lymph node mapping and biopsy Receives: Procedure: Sentinel lymph node mapping and biopsy | |
| Lymphadenectomy group | woman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping Receives: Procedure: Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
The length of time from the day of operation till recurrence or last follow up
Measured: 4 years
overall survival
The length of time from the day of operation till death (of any cause) or last follow up
Measured: 4 years
Secondary outcomes (1)
surgical complications related to lymph node biopsy or lymphadenectomy
asymptomatic lymphocele, lymphedema, infected lymphocele
Measured: from the day of operation till post-operative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Oct 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Endometrial CancerStudies 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
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048173
- Sponsor's protocol ID
- 110187-E
- Status last verified
- Sep 2023
- First submitted
- 18 Dec 2020
- Last updated
- 15 Sep 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early Stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05048173
- Acronym / sponsor ID
- 110187-E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 17 Sep 2021 (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 compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.
Detailed description
This retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node group | – | Procedure: Sentinel lymph node mapping and biopsywoman who had sentinel lymph node mapping and biopsy |
| Lymphadenectomy group | – | Procedure: Lymphadenectomywoman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 20 and above, diagnosed with early stage endometrial cancer (FIGO stage I), who had received staging surgery between 01 July 2017 and 19 August 2021 were included in the study.
Key inclusion criteria (2 listed)
- ≧ 20 years
- early stage endometrial cancer (FIGO stage I)
Key exclusion criteria (1 listed)
- Did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.
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 |
|---|---|---|
| Sentinel lymph node mapping and biopsySentinel lymph node mapping with indocyanine green dye followed by biopsy if positive | Procedure or surgery | Sentinel lymph node group |
| LymphadenectomyConventional lymphadenectomy | Procedure or surgery | Lymphadenectomy group |
Primary outcome
progression free survival
Time frame: 4 years
The length of time from the day of operation till recurrence or last follow up
overall survival
Time frame: 4 years
The length of time from the day of operation till death (of any cause) or last follow up
1 secondary outcome
surgical complications related to lymph node biopsy or lymphadenectomy
Time frame: from the day of operation till post-operative 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Early Stage Endometrial Cancer and Sentinel Lymph Nodes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 15 Sep 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 4 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?
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 15 Sep 2023.