Col

TITRE Étude internationale de validation de la biopsie du ganglion sentinelle dans le cancer du col de l’utérus au stade précoce
PROTOCOLE ID SENTICOL III
CLINICAL TRIAL.gov ID NCT03386734
TYPE(S) DE CANCER Col
PHASE Autres
TYPE D'ÉTUDE Clinique
INSTITUTION CHUM
1051 rue Sanguinet
(514) 890-8000
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Vanessa Samouëlian
COORDONATEUR(RICE) France Gauthier
france.gauthier.chum@ssss.gouv.qc.ca
514-890-8000 poste 30921
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy),
  • Stage Ia1 with lymphovascular emboli, Ia2, Ib1 and IIa1 (clinical stage) of the 2009 FIGO classification,
  • Maximum diameter ≤ 40 mm by clinical examination and magnetic resonance imaging (MRI),
  • INo suspicious node on pelvic and abdominal MRI with an exploration up to the femoralleft renal vein (according to RECIST 1.1),
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2,
  • Signed informed consent and ability to comply with follow-up,
CRITÈRES D'EXCLUSION (EN)
  • Pregnancy,
  • Previous pelvic or abdominal cancer,
  • Previous chemotherapy and/or radiation therapy for the cervical cancer (previous brachytherapy is accepted),
  • Proven allergy to blue dye, isotope or indocyanine green (ICG).