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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC-K14-184 | Other Grant/Funding Number | DGOS/INCA | |
| 2024-513079-42-00 | EU Trial (CTIS) Number | ||
| 2015-001732-38 | EudraCT Number |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Canceropôle Nord Ouest | OTHER |
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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).
Routine exams required for diagnosis:
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)*
Second tumor board: after definitive pathological results of the hysterectomy-annexectomy and node (sentinel or not) specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| B : Current initial staging protocols | Other | Current initial staging protocols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative SN mapping with radionucleide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of detected sentinel node | number of patients with ≥ 1 Sentinel Node (SN) / total number of explored patients, and bilaterality | During surgery |
| Rate of pN1 | n pN1 / total N |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lucie BRESSON, MD | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Urbain V | Avignon | 84036 | France | |||
| Centre Hospitalier Régional Universitaire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34195683 | Result | 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. |
| Label | URL |
|---|---|
| Results of proteomics profiling of sentinel lymph nodes | View source |
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|
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| Intra-operative SN mapping with patent V blue dye | Drug |
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| Intra-operative SN mapping with indocyanin green | Drug | 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 |
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| Full bilateral laparoscopic lymphadenectomy and Hysterectomy | Procedure |
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| Current initial staging protocols | Procedure | Current French initial staging protocols |
|
| 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. | 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). | 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. | an average of 1 month after surgery |
| Proteomic signature of positive SN | Detection of SN involvement with proteomics | an average of 1 year after surgery |
| Besançon |
| 25000 |
| France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Georges François Leclerc | Dijon | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hôpital Jeanne de Flandres, CHRU Lille | Lille | 59037 | France |
| Hôpital Mère-Enfant, CHU Limoges | Limoges | 87042 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| ICM Val d'Aurelle | Montpellier | 34298 | France |
| Hôpital La Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Institut de Cancérologie de l'Ouest, René Gauducheau | Saint-Herblain | 44805 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D018269 | Carcinoma, Endometrioid |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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