Syracuse

Centralized investigator review of radiological and functional imaging reports in real‐world oncology studies: The SACHA‐France experience

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Berlanga, Pablo | Aerts, Isabelle | Corradini, Nadège | Ndounga-Diakou, Lee Aymar | Entz-Werle, Natacha | Ducassou, Stéphane | André, Nicolas | Sevrin, François | Chastagner, Pascal | Puiseux, Chloe | Cleirec, Morgane | Plantaz, Dominique | de Carli, Emilie | Gambart, Marion | Khanfar, Camille | Thouvenin, Sandrine | Petit, Arnaud | Klein, Sébastien | Briandet, Claire | Millot, Frédéric | Pluchart, Claire | Reguerre, Yves | Schneider, Pascale | Serre, Jill | Halfon-Domenech, Carine | Carausu, Liana | Piguet, Christophe | Saumet, Laure | Benadiba, Joy | Abbou, Samuel | Laghouati, Salim | Geoerger, Birgit | Vassal, Gilles

Edité par CCSD ; Wiley -

International audience. SACHA‐France (NCT04477681) is a prospective real‐world study that collects clinical safety and efficacy data of novel anticancer therapies prescribed off‐label or on compassionate use to patients <25 years. From March 2020 until February 2024, 640 patients with solid tumors or lymphomas were included, with 176 (28%) reported objective tumor responses. Centralized medical monitoring of local radiological/functional imaging reports by the SACHA coordinating investigator led to response modification in 45 out of 176 cases (26%), highlighting the relevance of the medical review of study data. We suggest this pragmatic approach for improving clinical trial data when centralized radiological review is not performed.

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