Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High… (NCT02598219) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.
France262 participantsStarted 2015-11
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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
Exclusion criteria
✕. Preoperative workup with :
✕. Pregnant and/or breastfeeding woman
✕. No understanding of the trial
✕. Patient deprived of liberty or in guardianship