Cancer of EndometriumSNENCT02545348
Use of the Sentinel Node Biopsy for Early Endometrial Cancer.
An observational study of Cancer of Endometrium, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 10 sites in Belgium.
Trial summary
This is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. The collaborating centres with the OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc will also particpate to the trial. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cancer of Endometrium
- What is being tested?
- Sentinel Lymph Node Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 10 sitesBelgium
- Study dates
- Aug 2015to Sep 2020
- 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 the patient with early stage endometrial cancer, whith or without indication of complete lymphadenectomy
Who may be able to join
- Endometrial cancer early stage on the pre operative examinations
- Performance status that allow a surgery
- Surgery by laparoscopy or laparotomy
Who cannot join
- Patient already operated of the hysterectomy who need lymphatic restadification
- Stage IV disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites, 10 recruiting
- Recruiting
Cliniques de l'Europe
Brussels, 1180
Marc Waterkeyn, marcwaterkeyn@yahoo.fr
Alain Charles
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Mathieu Luyckx, 27646009 ext. +32, mathieu.luyckx@uclouvain.be
Jean-Luc Squifflet, 27641071 ext. +32, jean-luc.squifflet@uclouvain.be
- Recruiting
Clinique St Jean
Brussels
Jean-Paul Van gossum, MD, jpvangossum@clstjean.be
- Recruiting
Cliniques Saint-Anne - Saint Remi
Brussels
Bruno Vandermeersch, MD, bruno.vandermeersch@skynet.be
- Recruiting
Hôpital d'Ixelles
Brussels
Frédéric BUXANT, MD, FBUXANT@his-izz.be
- Not yet recruiting
GHDC
Charleroi, 6000
Timour Willems
- Recruiting
Université de Liège
Liège, 6000
Frédéric Kridelka, PhD, 04/367.95.19, frederic.kridelka@chu.ulg.ac.be
- Recruiting
CHU AMbroise Parée
Mons, Hainaut
Kurt Crener, MD, Kurt.Crener@hap.be
- Recruiting
Cliniques Saint-Pierre Ottignies
Ottignies, 1340
Vincent Malvaux, Vincent.MALVAUX@cspo.be
- Recruiting
CHWaPi
Tournai, 7500
Mathieu Jouret, Mathieu.JOURET@chwapi.be
Marc Wayemberg
About this study
Official title: Evaluation (Good Medical Practice Evaluation) of the Use of the Sentinel Node Biopsy in Early Stage Endometrial Cancer and Its Implication on the Adjuvant Treatement and on the Outcomes of the Cancer
This is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. The collaborating centres with the OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc will also particpate to the trial.
Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading team in the world published very good result and that the first prospectives trials are already published with also excellents results. The investigators decided then to include this practice in their institutional guideslines and also to registred the procedure.
Read the detailed description
All the sentinel node biopsy procedures for endometrial cancer will be record online via the REDCap tools, securized on a servor in Saint-Luc. Automatic email for the following of the patients and the post operative event will be send regularly for every patient to the physicians who include the patient. Efficacy of the technique, False negative and postive rate, modifications of the adjuvant treatement, long terme evolution and complication wil be evaluate.
- Conditions
- Cancer of Endometrium
- Being tested
- Sentinel Lymph Node Biopsy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node BiopsyProcedure or surgery
First, the detection of the sentinel node will be preformed at the beginning of the surgery. Differents detection methods are use and the efficacy of each will be recorded. Second, dissection and extraction of the sentinel node will be performed, to send it to the frozen section examination. Third, other lymph node could be removed if the surgeon evaluate that it is feasible and necessary. In this group, the false negative rate will be also evaluate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
Each hemi pelvis is count as an unit for the detection rate, but also the detection per patient will be calculated. For a positive detection with the patient as an unit, the detection must be bilateral
Measured: 5 years
Secondary outcomes (5)
Modification of the adjuvant treatement by the information bring by the sentinel node analysis
An evaluation of the modification of the adjuvant treatement by the results of the node sentinel will be performed, in case of it was performed alone and then compared to the guides lines when no information on the nodal status is knowed. It will also be evaluated in cas where a complete lymphadenectomy was performed to evaluate the interest of the ultrastaging on the sentinel node.
Measured: 5 years
Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.
Influence of the use of the sentinel node only or in addition to the complete lymphadenectomy on the DFS and the OS by comparing with the litterature accorded DFS and OS will be evaluate. Type of reccurence will also be attentively observed, in order to ensure the safety of the sentinel node dissection only. If the technique is reliable, the rate of nodal reccurence after negative sentinel node should be low.
Measured: 5 years
False positive rate of the frozen section analysis
Each negative sentinel node at the frozen section analyse wil also undergo a second analysis after "calssical" preparation of the tissue and alos immunochemestry analysis
Measured: 5 years
False negative rate of the sentinel node, after frosen section analyse and the complete analysis
In the group of patient who underwent a complet lymphadenectomy, a false negative rate will be calculate, with a expected number really low.
Measured: 5 years
Early and late complications of the procedure
Per operative, early and late post operative complication related to the sentinel node procedure will be recorded in the REDCap file, and will be compared to the group of complete lymphadenectomy, with a special focus on lymphatics complications (lymphocyst, lymphoedema,...)
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 posted9 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of EndometriumStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luyckx, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Luyckc Luyckx, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545348
- Sponsor's protocol ID
- StLucGsendo1
- Acronym
- SNE
- Status last verified
- Dec 2019
- First submitted
- 3 Sep 2015
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation (Good Medical Practice Evaluation) of the Use of the Sentinel Node Biopsy in Early Stage Endometrial Cancer and Its Implication on the Adjuvant Treatement and on the Outcomes of the Cancer
- ClinicalTrials.gov ID
- NCT02545348
- Acronym / sponsor ID
- SNE / StLucGsendo1
- Conditions
- Cancer of Endometrium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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 is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. The collaborating centres with the OncoGynecology board of the King Albert II Institute of the Clinique Universitaire Saint-Luc will also particpate to the trial.
Sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading team in the world published very good result and that the first prospectives trials are already published with also excellents results. The investigators decided then to include this practice in their institutional guideslines and also to registred the procedure.
Detailed description
All the sentinel node biopsy procedures for endometrial cancer will be record online via the REDCap tools, securized on a servor in Saint-Luc. Automatic email for the following of the patients and the post operative event will be send regularly for every patient to the physicians who include the patient. Efficacy of the technique, False negative and postive rate, modifications of the adjuvant treatement, long terme evolution and complication wil be evaluate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patient with early stage endometrial cancer, whith or without indication of complete lymphadenectomy
Key inclusion criteria (3 listed)
- Endometrial cancer early stage on the pre operative examinations
- Performance status that allow a surgery
- Surgery by laparoscopy or laparotomy
Key exclusion criteria (2 listed)
- Patient already operated of the hysterectomy who need lymphatic restadification
- Stage IV disease
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 BiopsyFirst, the detection of the sentinel node will be preformed at the beginning of the surgery. Differents detection methods are use and the efficacy of each will be recorded. Second, dissection and extraction of the sentinel node will be performed, to send it to the frozen section examination. Third, other lymph node could be removed if the surgeon evaluate that it is feasible and necessary. In this group, the false negative rate will be also evaluate. | Procedure or surgery | – |
Primary outcome
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators
Time frame: 5 years
Each hemi pelvis is count as an unit for the detection rate, but also the detection per patient will be calculated. For a positive detection with the patient as an unit, the detection must be bilateral
5 secondary outcomes
Modification of the adjuvant treatement by the information bring by the sentinel node analysis
Time frame: 5 years
Survival outcomes: Disease free survival (DFS) and Overvall survival (OS) will be evaluate.
Time frame: 5 years
False positive rate of the frozen section analysis
Time frame: 5 years
False negative rate of the sentinel node, after frosen section analyse and the complete analysis
Time frame: 5 years
Early and late complications of the procedure
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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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.
Luyckc Luyckx principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Endometrium, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 10 sites in Belgium.
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 3 inclusion and 2 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. 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 Mathieu LUYCKX (27649509 ext. +32, mathieu.luyckx@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of the sentinel lymph node biopsy regarding diffrent methods used by the investigators (time frame: 5 years). 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 16 Dec 2019.