Informations générales (source: ClinicalTrials.gov)
International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer (SENTICOLIII)
Interventional
N/A
Centre Hospitalier Universitaire de Besancon (Voir sur ClinicalTrials)
mai 2018
mai 2029
09 juillet 2024
SENTICOL III is large prospective multicenter international randomized study designed to
validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This
"validation study" will compare the outcome of patients with negative SLN (experimental
arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm).
There will be a "quality assurance" program which will be developed in participating
centers with detailed requirements in terms of surgeons' qualifications, pathology
qualification, SLN ultrastaging, standardization of the procedure, etc. as well as
respect of the "safety algorithm".
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Jennifer UZAN | 29/03/2024 01:28:09 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:48 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | S�bastien GOUY | 19/06/2024 08:14:18 | Contact (sur clinicalTrials) | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:32 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Center de Lutte Contre le Cancer François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte Contre le Cancer Antoine Lacassagne - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre de Lutte Contre le Cancer Jean Perrin - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Henri Becquerel - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Godinot - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| CH de Mulhouse - Hôpital du Hasenrain - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| CH Lyon Sud - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| CHI de Créteil - 94000 - Créteil - France | Contact (sur clinicalTrials) | ||||
| CHRU de Lille - Hôpital Jeanne de Flandre - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU d'Amiens - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU de Besançon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU de Caen - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Clermont-Ferrand - Hôpital d'Estaing - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon Bourgogne - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU de la Réunion - 97400 - Saint-Denis - La Réunion - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU de Poitiers - Hôpital de la Milétrie - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU de Reims - Hôpital Robert Debré - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Hôpital Sud - Rennes - France | Contact (sur clinicalTrials) | ||||
| Clinique Mathilde - 76100 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Clinique Tivoli-Ducos - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Grand Hôpital de l'Est Francilien - 77420 - Paris - Marne-le-Vallée - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier la Pitié Salpêtrière - Paris - France | Contact (sur clinicalTrials) | ||||
| Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Antoine Béclère - 92140 - Clamart - France | Contact (sur clinicalTrials) | ||||
| Hôpital Bicêtre - 94270 - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Conception - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpital de Poissy-Saint-Germain-en-Laye - Poissy - France | Contact (sur clinicalTrials) | ||||
| Hôpital Lariboisière - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Joseph - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux Universitaires de Strasbourg - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine - 54500 - Vandoeuvre les nancy - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Centre René Gauducheau - Nantes - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Montpellier Val d'Aurelle - 34000 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer de Toulouse - 31000 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or
adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1
with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO
classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination
and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an
exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance
status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with
follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in
this study only if either affiliated to, or a beneficiary of, a social security category.
I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or
adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1
with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO
classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination
and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an
exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance
status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with
follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in
this study only if either affiliated to, or a beneficiary of, a social security category.
E 1. Pregnancy, E 2. Previous pelvic or abdominal cancer, E 3. Previous chemotherapy
and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted), E
4. Proven allergy to blue dye, isotope or indocyanine green (ICG) E 5. Other malignancy
within the last 5 years except for treated cancer free of disease and treatment, E 6.
Patients with synchronous cancer