Endometrial CancerENDO-GREENNCT04958278
Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve
An observational study of Endometrial Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 31 Oct 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 18 years and older
- Women only
- Adult, Older adult
Study population: 30 patients over 18 months total duration of the study 20 months
Who may be able to join
- Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.
Who cannot join
- Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO > II Suspected Indocyanine Green allergy
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Brest
Brest, 29609
Pierre-François DUPRE, pierre-francois.dupre@chu-brest.fr
About this study
Official title: Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
Read the detailed description
Introduction:
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
Patients and Method:
All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled.
Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection.
Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate .
Thirty patients will be included over 18 months.
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral node detection rates
target = 70% to 90%
Measured: Day 0 (during surgery)
Secondary outcomes (4)
sentinel nodes
number of sentinel nodes collected
Measured: Day 0 (during surgery)
Salvage operations in case of GS failure
Number of salvage operations
Measured: Day 0 (during surgery)
adverse events
Per and post operative adverse events according to Clavine Dindo Classification
Measured: Day 30
factors for detection failure
Measured: Day 0 (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958278
- Sponsor's protocol ID
- ENDO-GREEN ( 29BRC21.0078)
- Acronym
- ENDO-GREEN
- Status last verified
- Apr 2021
- First submitted
- 1 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04958278
- Acronym / sponsor ID
- ENDO-GREEN / ENDO-GREEN ( 29BRC21.0078)
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 12 Jul 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.
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
Detailed description
Introduction:
According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri.
The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.
Patients and Method:
All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled.
Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection.
Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate .
Thirty patients will be included over 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 30 patients over 18 months total duration of the study 20 months
Key inclusion criteria (1 listed)
- Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.
Key exclusion criteria (1 listed)
- Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO > II Suspected Indocyanine Green allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bilateral node detection rates
Time frame: Day 0 (during surgery)
target = 70% to 90%
4 secondary outcomes
sentinel nodes
Time frame: Day 0 (during surgery)
Salvage operations in case of GS failure
Time frame: Day 0 (during surgery)
adverse events
Time frame: Day 30
factors for detection failure
Time frame: Day 0 (during surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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 Endometrial Cancer, run by University Hospital, Brest at 1 site in France.
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 12 Jul 2021. 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 France. 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 Pierre-François DUPRE, MD (+33 2 98 22 37 59, pierre-françois.dupre@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral node detection rates (time frame: Day 0 (during 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 12 Jul 2021.