早期子宮頸がんにおけるセンチネルリンパ節生検の国際検証研究

基本情報

NCT ID: NCT03386734
ステータス: 実施中（募集終了）
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 989
治験依頼者名: Centre Hospitalier Universitaire de Besancon

概要

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".

対象疾患

Cervical Cancer

介入

SLN biopsy only(PROCEDURE)

SLN biopsy + PLN dissection(PROCEDURE)

依頼者（Sponsor）

Centre Hospitalier Universitaire De Besancon(OTHER)

European Network Of Gynaecological Oncological Trial Groups (Engot)(OTHER)

Arcagy/ Gineco Group(OTHER)

実施施設 (1)

埼玉医科大学国際医療センター

Saitama, Japan