Centralized Investigator Review of Radiological and Functional Imaging Reports in Real‐World Oncology Studies: The SACHA‐France Experience
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.
Authors
- Nadège Corradini (ORCID: https://orcid.org/0000-0002-1942-1222)
- Isabelle Aerts (ORCID: https://orcid.org/0000-0002-5213-3353)
- Chloé Puiseux
- Salim Laghouati (ORCID: https://orcid.org/0000-0003-0888-0842)
- Yves Réguerre (ORCID: https://orcid.org/0000-0001-7192-046X)
- Morgane Cleirec (ORCID: https://orcid.org/0000-0002-8749-9443)
- Claire Pluchart (ORCID: https://orcid.org/0000-0002-5500-969X)
- Camille Khanfar (ORCID: https://orcid.org/0009-0009-5404-8417)
- Natacha Entz‐Werlé (ORCID: https://orcid.org/0000-0001-8418-7439)
- Carine Halfon‐Domenech
- Pablo Berlanga (ORCID: https://orcid.org/0000-0003-1110-7789)
- Jill Serre
- Dominique Plantaz (ORCID: https://orcid.org/0000-0002-9780-0914)
- Laure Saumet
- Arnaud Petit (ORCID: https://orcid.org/0000-0001-8363-1622)
- Stéphane Ducassou (ORCID: https://orcid.org/0000-0001-7736-0838)
- P. Chastagner
- Sébastien Klein (ORCID: https://orcid.org/0009-0002-8846-3239)
- Sandrine Thouvenin (ORCID: https://orcid.org/0000-0003-1496-3898)
- Claire Briandet (ORCID: https://orcid.org/0009-0009-4663-9815)
- Birgit Geoerger (ORCID: https://orcid.org/0000-0003-4361-3643)
- Nicolás André (ORCID: https://orcid.org/0000-0002-6786-4968)
- François Sevrin (ORCID: https://orcid.org/0009-0005-8824-2729)
- Joy Benadiba (ORCID: https://orcid.org/0000-0003-4229-7749)
- Émilie De Carli
- Pascale Schneider
- Gilles Vassal (ORCID: https://orcid.org/0000-0003-1780-8869)
- Liana Carausu
- Samuel Abbou (ORCID: https://orcid.org/0000-0002-7159-8869)
- Marion Gambart
- Lee Aymar Ndounga‐Diakou (ORCID: https://orcid.org/0000-0001-5979-1714)
- Frédéric Millot (ORCID: https://orcid.org/0000-0002-8912-4776)
- Christophe Piguet
Institutions
- Centre National de la Recherche Scientifique (FR)
- Inserm (FR)
- Université Fédérale de Toulouse Midi-Pyrénées (FR)
- Aix-Marseille Université (FR)
- Université Paris Sciences et Lettres (FR)
- Université Paris-Saclay (FR)
- Institut Gustave Roussy (FR)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Centre Hospitalier Universitaire de Nice (FR)
- Centre Hospitalier Universitaire de Nantes (FR)
- Sorbonne Université (FR)
- Hôpital Armand-Trousseau (FR)
- Centre Hospitalier Universitaire de La Réunion (RE)
- Centre Hospitalier Universitaire de Besançon (FR)
- Centre Hospitalier Universitaire de Montpellier (FR)
- Centre Hospitalier Universitaire de Tours (FR)
- Centre Hospitalier Universitaire Amiens-Picardie (FR)
- Centre Hospitalier Régional et Universitaire de Nancy (FR)
- Hospices Civils de Lyon (FR)
- Centre Hospitalier Universitaire de Reims (FR)
- Centre Hospitalier Universitaire de Poitiers (FR)
- CHU Dijon Bourgogne (FR)
- Centre Hospitalier Universitaire de Limoges (FR)
- Centre Oscar Lambret (FR)
- Centre Hospitalier Régional Universitaire de Brest (FR)
- Centre Hospitalier Universitaire de Rouen (FR)
- Centre Hospitalier Universitaire de Rennes (FR)
- Centre Hospitalier Universitaire de Saint-Étienne (FR)
- Université d'Angers (FR)
- Université de Rouen Normandie (FR)
- Institut Curie (FR)
- Université Grenoble Alpes (FR)
- Université de Reims Champagne-Ardenne (FR)
Publication Details
- Journal
- Pediatric Blood & Cancer
- Published
- 2024-11-19
- DOI
- https://doi.org/10.1002/pbc.31449
- Citations
- 1
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 1.13