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

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

doi:10.1002/pbc.31449

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

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

Résultats de recherche: Contribution à un journal › Article › Revue par des pairs

Résumé

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.

langue originale	Anglais
journal	Pediatric Blood and Cancer
Les DOIs	https://doi.org/10.1002/pbc.31449
état	Accepté/sous presse - 1 janv. 2024

Accès au document

10.1002/pbc.31449

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Berlanga, P., Aerts, I., Corradini, N., Ndounga-Diakou, L. A., Entz-Werle, N., Ducassou, S., André, N., Sevrin, F., Chastagner, P., Puiseux, C., Cleirec, M., Plantaz, D., De Carli, E., Gambart, M., Khanfar, C., Thouvenin, S., Petit, A., Klein, S., Briandet, C., ... Vassal, G. (Accepté/en presse). Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience. Pediatric Blood and Cancer. https://doi.org/10.1002/pbc.31449

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

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",

author = "Pablo Berlanga and Isabelle Aerts and Nad{\`e}ge Corradini and Ndounga-Diakou, {Lee Aymar} and Natacha Entz-Werle and St{\'e}phane Ducassou and Nicolas Andr{\'e} and Fran{\c c}ois Sevrin and Pascal Chastagner and Chloe Puiseux and Morgane Cleirec and Dominique Plantaz and {De Carli}, Emilie and Marion Gambart and Camille Khanfar and Sandrine Thouvenin and Arnaud Petit and S{\'e}bastien Klein and Claire Briandet and Fr{\'e}d{\'e}ric Millot and Claire Pluchart and Yves Reguerre and Pascale Schneider and Jill Serre and Carine Halfon-Domenech and Liana Carausu and Christophe Piguet and Laure Saumet and Joy Benadiba and Samuel Abbou and Salim Laghouati and Birgit Geoerger and Gilles Vassal",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s). Pediatric Blood & Cancer published by Wiley Periodicals LLC.",

year = "2024",

month = jan,

day = "1",

doi = "10.1002/pbc.31449",

language = "English",

journal = "Pediatric Blood and Cancer",

issn = "1545-5009",

}

Berlanga, P, Aerts, I, Corradini, N, Ndounga-Diakou, LA, Entz-Werle, N, Ducassou, S, André, N, Sevrin, F, Chastagner, P, Puiseux, C, Cleirec, M, Plantaz, D, De Carli, E, Gambart, M, Khanfar, C, Thouvenin, S, Petit, A, Klein, S, Briandet, C, Millot, F, Pluchart, C, Reguerre, Y, Schneider, P, Serre, J, Halfon-Domenech, C, Carausu, L, Piguet, C, Saumet, L, Benadiba, J, Abbou, S, Laghouati, S, Geoerger, B & Vassal, G 2024, 'Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies: The SACHA-France Experience', Pediatric Blood and Cancer. https://doi.org/10.1002/pbc.31449

TY - JOUR

T1 - Centralized Investigator Review of Radiological and Functional Imaging Reports in Real-World Oncology Studies

T2 - The SACHA-France Experience

AU - Berlanga, Pablo

AU - Aerts, Isabelle

AU - Corradini, Nadège

AU - Ndounga-Diakou, Lee Aymar

AU - Entz-Werle, Natacha

AU - Ducassou, Stéphane

AU - André, Nicolas

AU - Sevrin, François

AU - Chastagner, Pascal

AU - Puiseux, Chloe

AU - Cleirec, Morgane

AU - Plantaz, Dominique

AU - De Carli, Emilie

AU - Gambart, Marion

AU - Khanfar, Camille

AU - Thouvenin, Sandrine

AU - Petit, Arnaud

AU - Klein, Sébastien

AU - Briandet, Claire

AU - Millot, Frédéric

AU - Pluchart, Claire

AU - Reguerre, Yves

AU - Schneider, Pascale

AU - Serre, Jill

AU - Halfon-Domenech, Carine

AU - Carausu, Liana

AU - Piguet, Christophe

AU - Saumet, Laure

AU - Benadiba, Joy

AU - Abbou, Samuel

AU - Laghouati, Salim

AU - Geoerger, Birgit

AU - Vassal, Gilles

PY - 2024/1/1

Y1 - 2024/1/1

N2 - 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.

AB - 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.

KW - clinical trials

KW - oncology

KW - pediatric oncology

KW - solid

KW - tumors

UR - http://www.scopus.com/inward/record.url?scp=85209630072&partnerID=8YFLogxK

U2 - 10.1002/pbc.31449

DO - 10.1002/pbc.31449

M3 - Article

AN - SCOPUS:85209630072

SN - 1545-5009

JO - Pediatric Blood and Cancer

JF - Pediatric Blood and Cancer

ER -