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Observational Study
. 2025 Feb;72(2):e31449.
doi: 10.1002/pbc.31449. Epub 2024 Nov 19.

Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience

Pablo Berlanga  1 , Isabelle Aerts  2 , Nadège Corradini  3 , Lee Aymar Ndounga-Diakou  4 , Natacha Entz-Werle  5 , Stéphane Ducassou  6 , Nicolas André  7 , François Sevrin  8 , Pascal Chastagner  9 , Chloe Puiseux  10 , Morgane Cleirec  11 , Dominique Plantaz  12 , Emilie De Carli  13 , Marion Gambart  14 , Camille Khanfar  15 , Sandrine Thouvenin  16 , Arnaud Petit  17 , Sébastien Klein  18 , Claire Briandet  19 , Frédéric Millot  20 , Claire Pluchart  21 , Yves Reguerre  22 , Pascale Schneider  23 , Jill Serre  24 , Carine Halfon-Domenech  25 , Liana Carausu  26 , Christophe Piguet  27 , Laure Saumet  28 , Joy Benadiba  29 , Samuel Abbou  1 , Salim Laghouati  4 , Birgit Geoerger  1   30 , Gilles Vassal  1
Affiliations
Observational Study

Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience

Pablo Berlanga et al. Pediatr Blood Cancer. 2025 Feb.

Abstract

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.

Keywords: clinical trials; oncology; pediatric oncology; solid; tumors.

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References

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