Non Endometrioid CarcinomaPhase 3SENTIRADNCT02598219
Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.
A Phase 3 study testing Pre-operative SN mapping with radionucleide, Intra-operative SN mapping with patent V blue dye and Intra-operative SN mapping with indocyanin green in people with Non Endometrioid Carcinoma and Endometrioid Carcinoma, run by Centre Oscar Lambret at 16 sites in France.
Trial summary
The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non Endometrioid Carcinoma, Endometrioid Carcinoma
- What is being tested?
- Pre-operative SN mapping with radionucleide, Intra-operative SN mapping with patent V blue dye and Intra-operative SN mapping with indocyanin green
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 16 sitesFrance
- Study dates
- 19 Nov 2015to 26 Aug 2026
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI not possible - and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last European Society for Medical Oncology (ESMO) guidelines :
- Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
- Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
- Or High risk non endometrioid (type 2) : FIGO stages I-II
- Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
- Age ≥ 18 years
Show all 12Show fewer
- Performance status (OMS) ≤ 2
- No contraindication to surgery
- Absence of known hypersensitivity to colloidal rhenium sulphide and technetium (nanocolloid) or one of its excipients, to human albumin preparations, to Nanocoll® and Rotop-nanoHSA® and their excipients, to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, to triphenylmethane derivatives
- Signed and dated informed consent
- Effective contraception for patients with reproductive potential
- Patient affiliated with a health insurance system
Who cannot join
- Preoperative workup with :
- Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure)
- non carcinoma (for example sarcoma, trophoblastic tumor)
- Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
- Metastatic disease at preoperative workup
- Suspicious adenopathy at preoperative workup
Show all 10Show fewer
- Pregnant and/or breastfeeding woman
- No understanding of the trial
- Patient deprived of liberty or in guardianship
- Inexperience of the trial site in pelvic sentinel node detection
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Polyclinique Urbain V
Avignon, 84036
Centre Hospitalier Régional Universitaire
Besançon, 25000
Institut Bergonié
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges François Leclerc
Dijon
Centre Oscar Lambret
Lille, 59020
Hôpital Jeanne de Flandres, CHRU Lille
Lille, 59037
Hôpital Mère-Enfant, CHU Limoges
Limoges, 87042
Centre Léon Bérard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
ICM Val d'Aurelle
Montpellier, 34298
Hôpital La Pitié-Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris, 75015
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67065
Institut Claudius Regaud
Toulouse, 31059
About this study
Official title: Randomized Trial Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence
The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).
Read the detailed description
- Routine exams required for diagnosis:
- Endometrioid biopsy or product of a dilatation-curettage under hysteroscopy for diagnosis of histologic typing
- Tumor assessment: Lombopelvic MRI (1.5 or 3T) with gadolinium injection, studied by steady and dynamic sequences. US and CT-Scan in case of intolerance to MRI should be discussed. FDG-PET may be an option.
- Tumor board: The completed chart will be reviewed to confirm the risk group and indication.
- Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.
- Informed and signed consent form.
- Study baseline assessment. Then,
- Surgery should be performed within a maximum of 4 weeks from the first consultation, according arm allocated: Arm A: Sentinel node policy* Arm B:
- Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
- Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
- Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)*
- along with a peritoneal staging for each arm (cytology, random biopsies, infracolic omentectomy)
- Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.
- Conditions
- Non Endometrioid Carcinoma, Endometrioid Carcinoma
- Being tested
- Pre-operative SN mapping with radionucleide, Intra-operative SN mapping with patent V blue dye, Intra-operative SN mapping with indocyanin green, Full bilateral laparoscopic lymphadenectomy and Hysterectomy, Current initial staging protocols
- Keywords
- Sentinel node
- Medical subject headings
- Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative SN mapping with radionucleideDrug
Also called Pre-operative Sentinel Node
- Preparation : four 1ml syringe (Nanocis, or Nanocoll, or Rotop-nanoHSA) are prepared per patient, each containing a total activity 10 MBq if the injection is planned the same day of surgery and in the operative theater OR each containing a total activity 30MBq if the injection is performed the day before the surgery.
- Intracervical injection is performed by the surgeon, no more than 3-24 hours before surgery : 4 submucous injections with the filtered radiocolloid at 3, 6, 9 and 12 o'clock positions. Each injection if performed at 2 mm of depth for a total activity of 40 MBq or a total activity of 120 MBq is the surgery is planned the day after the injection.
- Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available.
Intra-operative SN mapping with patent V blue dyeDrug
Also called Intra-operative SN mapping
- Patent blue V dye are diluted with saline sterile solution to obtain 4ml of 50%. Four 1ml syringe, each containing a 50% patent blue dye solution, are prepared per patient.
- Intracervical injection is performed by the surgeon. after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible.
- SN are detected by direct visualization of blue colored lymphatics and node
Intra-operative SN mapping with indocyanin greenDrug
Also called Intra-operative Sentinel Node (SN) mapping with Infracyanine
1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient.
2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible
3- SN detection by near-infrared fluorescence imaging
Full bilateral laparoscopic lymphadenectomy and HysterectomyProcedure or surgery
Also called Full bilateral lymphadenectomy
- Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
- Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
- Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)
Current initial staging protocolsProcedure or surgery
Current French initial staging protocols
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative SN mapping with radionucleide | Experimental | 1 Pre-operative Sentinel Node (SN) mapping with Nanocis or Nanocoll or Rotop-nanoHSA
2- Intra-operative SN mapping with patent V blue dye, or Intra-operative SN mapping with indocyanin green for patients with known hypersensitivity, allergy to patent V blue dye
3- Full bilateral laparoscopic lymphadenectomy and Hysterectomy: If bilateral SN are detected, all positive SN are removed, then the surgeon proceeds to a total hysterectomy.
If unilateral SN are detected, surgeon will complete intervention with pelvic LN dissection on the opposite side, in accordance with risk group definition (ex: omentectomy for high-risk non endometrioid carcinomas).
If non SN are detected, surgeon will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic LND with more enlarged dissection regardless the pathology Receives: Drug: Pre-operative SN mapping with radionucleide; Drug: Intra-operative SN mapping with patent V blue dye; Drug: Intra-operative SN mapping with indocyanin green; Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy |
| B : Current initial staging protocols | Other | Current initial staging protocols Receives: Procedure: Current initial staging protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Per-operative morbidity will be assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents.
Early post-operative morbidity will be assessed up to 30 days and scored according to Clavien-Dindo scale. Distant complications, beyond day 30 for patients with no indication of a secondary surgical staging (e.g. secondary paraaortic dissection for pelvic pN1) will be evaluated in accordance with the NCI-CTCAE scale v4.03
Measured: Up to 3 after surgery
Secondary outcomes (6)
Rate of detected sentinel node
number of patients with ≥ 1 Sentinel Node (SN) / total number of explored patients, and bilaterality
Measured: During surgery
Rate of pN1
n pN1 / total N
Measured: an average of 1 month after surgery
Disease free survival
Time from the date of randomization to the first documentation of local, regional or distant disease or death, whichever occurs first.
Measured: Up to 5 years after surgery
Overall survival
Time from the date of randomization to the date of death (indicate if the death is due to disease progression or not).
Measured: Up to 5 years after surgery
Pronostic value of L1CAM on the risk of reccurrence
A standard staining with HES is carried out in a systematic manner as well as immunohistochemistry with polyclonal anti-L1CAM. If 10% or more of the tumor cells showed L1CAM staining, the sample is rated positive. The rate of L1CAM positive sample will be further correlated with the node involvement and disease recurrence.
Measured: an average of 1 month after surgery
Proteomic signature of positive SN
Detection of SN involvement with proteomics
Measured: an average of 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start19 Nov 2015
- Primary completion20 Sep 2024
- Study completion26 Aug 2026
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 Non Endometrioid CarcinomaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Canceropôle Nord Ouest
- Responsible party
- Sponsor
- Investigators
- Lucie BRESSON, MD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598219
- Sponsor's protocol ID
- SENTIRAD-1502
- Other IDs
- PHRC-K14-184, 2024-513079-42-00, 2015-001732-38, 2015
- Acronym
- SENTIRAD
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2015
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboulouard S, Wisztorski M, Duhamel M, Saudemont P, Cardon T, Narducci F, Lemaire AS, Kobeissy F, Leblanc E, Fournier I, Salzet M. In-depth proteomics analysis of sentinel lymph nodes from individuals with endometrial cancer. Cell Rep Med. 2021 Jun 15;2(6):100318. doi: 10.1016/j.xcrm.2021.100318. eCollection 2021 Jun 15.
PubMed 34195683
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence
- ClinicalTrials.gov ID
- NCT02598219
- Acronym / sponsor ID
- SENTIRAD / SENTIRAD-1502
- Conditions
- Non Endometrioid Carcinoma, Endometrioid Carcinoma
- Keywords
- Sentinel node
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Canceropôle Nord Ouest
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 5 Nov 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.
The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).
Detailed description
- Routine exams required for diagnosis:
- Endometrioid biopsy or product of a dilatation-curettage under hysteroscopy for diagnosis of histologic typing
- Tumor assessment: Lombopelvic MRI (1.5 or 3T) with gadolinium injection, studied by steady and dynamic sequences. US and CT-Scan in case of intolerance to MRI should be discussed. FDG-PET may be an option.
- Tumor board: The completed chart will be reviewed to confirm the risk group and indication.
- Complete physical and gynecological examination by surgical oncologist followed by a consultation of anesthesiology to confirm the operability of patient.
- Informed and signed consent form.
- Study baseline assessment. Then,
- Surgery should be performed within a maximum of 4 weeks from the first consultation, according arm allocated: Arm A: Sentinel node policy* Arm B:
- Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
- Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
- Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)*
- along with a peritoneal staging for each arm (cytology, random biopsies, infracolic omentectomy)
- Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative SN mapping with radionucleide | Experimental | Drug: Pre-operative SN mapping with radionucleide, Drug: Intra-operative SN mapping with patent V blue dye, Drug: Intra-operative SN mapping with indocyanin green, Procedure: Full bilateral laparoscopic lymphadenectomy and Hysterectomy1 Pre-operative Sentinel Node (SN) mapping with Nanocis or Nanocoll or Rotop-nanoHSA 2- Intra-operative SN mapping with patent V blue dye, or Intra-operative SN mapping with indocyanin green for patients with known hypersensitivity, allergy to patent V blue dye 3- Full bilateral laparoscopic lymphadenectomy and Hysterectomy: If bilateral SN are detected, all positive SN are removed, then the surgeon proceeds to a total hysterectomy. If unilateral SN are detected, surgeon will complete intervention with pelvic LN dissection on the opposite side, in accordance with risk group definition (ex: omentectomy for high-risk non endometrioid carcinomas). If non SN are detected, surgeon will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic LND with more enlarged dissection regardless the pathology |
| B : Current initial staging protocols | Other | Procedure: Current initial staging protocolsCurrent initial staging protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI not possible - and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last European Society for Medical Oncology (ESMO) guidelines :
- Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
- Age ≥ 18 years
- Performance status (OMS) ≤ 2
- No contraindication to surgery
Key exclusion criteria (10 listed)
- Preoperative workup with :
- Pregnant and/or breastfeeding woman
- No understanding of the trial
- Patient deprived of liberty or in guardianship
- Inexperience of the trial site in pelvic sentinel node detection
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 |
|---|---|---|
| Pre-operative SN mapping with radionucleideAlso: Pre-operative Sentinel Node1. Preparation : four 1ml syringe (Nanocis, or Nanocoll, or Rotop-nanoHSA) are prepared per patient, each containing a total activity 10 MBq if the injection is planned the same day of surgery and in the operative theater OR each containing a total activity 30MBq if the injection is performed the day before the surgery. 2. Intracervical injection is performed by the surgeon, no more than 3-24 hours before surgery : 4 submucous injections with the filtered radiocolloid at 3, 6, 9 and 12 o'clock positions. Each injection if performed at 2 mm of depth for a total activity of 40 MBq or a total activity of 120 MBq is the surgery is planned the day after the injection. 3. Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available. | Drug | Pre-operative SN mapping with radionucleide |
| Intra-operative SN mapping with patent V blue dyeAlso: Intra-operative SN mapping1. Patent blue V dye are diluted with saline sterile solution to obtain 4ml of 50%. Four 1ml syringe, each containing a 50% patent blue dye solution, are prepared per patient. 2. Intracervical injection is performed by the surgeon. after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible. 3. SN are detected by direct visualization of blue colored lymphatics and node | Drug | Pre-operative SN mapping with radionucleide |
| Intra-operative SN mapping with indocyanin greenAlso: Intra-operative Sentinel Node (SN) mapping with Infracyanine1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient. 2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible 3- SN detection by near-infrared fluorescence imaging | Drug | Pre-operative SN mapping with radionucleide |
| Full bilateral laparoscopic lymphadenectomy and HysterectomyAlso: Full bilateral lymphadenectomy* Bilateral pelvic lymphadenectomy (intermediate risk endometrioid) * Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid) * Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid) | Procedure or surgery | Pre-operative SN mapping with radionucleide |
| Current initial staging protocolsCurrent French initial staging protocols | Procedure or surgery | B : Current initial staging protocols |
Primary outcome
Morbidity
Time frame: Up to 3 after surgery
Per-operative morbidity will be assessed during surgery according to the Oslo classification of intraoperative unfavourable incidents. Early post-operative morbidity will be assessed up to 30 days and scored according to Clavien-Dindo scale. Distant complications, beyond day 30 for patients with no indication of a secondary surgical staging (e.g. secondary paraaortic dissection for pelvic pN1) will be evaluated in accordance with the NCI-CTCAE scale v4.03
6 secondary outcomes
Rate of detected sentinel node
Time frame: During surgery
Rate of pN1
Time frame: an average of 1 month after surgery
Disease free survival
Time frame: Up to 5 years after surgery
Overall survival
Time frame: Up to 5 years after surgery
Pronostic value of L1CAM on the risk of reccurrence
Time frame: an average of 1 month after surgery
Proteomic signature of positive SN
Time frame: an average of 1 year after surgery
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 2026.
- Results publication: PubMed 34195683Aboulouard S, Wisztorski M, Duhamel M, Saudemont P, Cardon T, Narducci F, Lemaire AS, Kobeissy F, Leblanc E, Fournier I, Salzet M. In-depth proteomics analysis of sentinel lymph nodes from individuals with endometrial cancer. Cell Rep Med. 2021 Jun 15;2(6):100318. doi: 10.1016/j.xcrm.2021.100318. eCollection 2021 Jun 15.
- Results of proteomics profiling of sentinel lymph nodesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non Endometrioid Carcinoma
Recruiting
Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
Carcinoma, Endometrioid, Fertility Preservation
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
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.
Lucie BRESSON, MD study director
Centre Oscar Lambret
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pre-operative SN mapping with radionucleide, Intra-operative SN mapping with patent V blue dye and Intra-operative SN mapping with indocyanin green in people with Non Endometrioid Carcinoma and Endometrioid Carcinoma, run by Centre Oscar Lambret at 16 sites 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 12 inclusion and 10 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 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Morbidity (time frame: Up to 3 after surgery). 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 NCT02598219, 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 15 Sep 2026.