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Authors
Mathonnet, Muriel https://orcid.org/0000-0002-9127-3068
Vanderstraete, Mathieu
Bounaix Morand du Puch, Christophe
Giraud, Stéphanie
Lautrette, Christophe
Ouaissi, Mehdi
Tabchouri, Nicolas
Taïbi, Abdelkader
Martin, Renaud
Herafa, Isabelle
Tchalla, Achille
Christou, Niki
,
Marin, B.
Bouvier, S.
Durand-Fontanier, S.
Fabre, A.
Valleix, D.
Rivaille, T.
Fredon, F.
Derbal, S.
Carrier, P.
Lonfo, R. Daloko
Legros, R.
Lavau-Denes, S.
Lebrun-Ly, V.
Thuillier, F.
Engel, P.
Chaunavel, A.
Pradel, M.
Pezet, D.
Dubois, A.
Pétorin, C.
Antomarchi, O.
Aboukassem, A.
Vimal-Baguet, A.
Gillet, B.
Mathieu, B.
Joubert-Zakeyh, J.
Evrard, S.
Becouarn, Y.
Béchade, D.
Fonk, M.
Desolneux, G.
Dauriat, N.
Agbo, M.
Louty, M.
Borie, F.
Lyubimova, S.
Phoutthasang, V.
Brunaud-Gagniard, B.
Benadjaoud, Y.
Rolland, N.
Letournoux, L.
Roger, P.
Chen, L.
Amadou, Z.
Christopoulous, C.
Nakahl, G.
Souliman, Y.
Cirt, M. N.
Ducoux, D.
Boisseau, P. A.
Pardies, P.
Mesturoux, L.
Vayre, L.
Abdeh, A.
Teboul, F.
Landraud, R.
Ouaissi, M.
Salamé, E.
Tabchouri, N.
Lecomte, T.
Proutheau, G.
Guyetant, S.
Tougeron, D.
de Singly, A.
Ferru, A.
El Fadel, R.
Courvoisier, T.
Junca, A.
Frouin, E.
Rouleau, L.
Rafaert, S.
Rocher, A.
Regimbeau, J-M
Sabbagh, C.
Dumange, E.
Chive, E.
Lignier, D.
Siembida, N.
Chauffert, B.
Hautefeuille, V.
Chatelain, D.
Rivkine, E.
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Article History
Received: 10 December 2020
Accepted: 9 August 2021
First Online: 21 August 2021
Declarations
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: The trial was approved by the “Comité de protection des personnes du Sud-Ouest et Outre-Mer IV” (institutional review board) on July 3, 2017 (registration number: 2017-A00120-53). Written, informed consent to participate will be obtained from all participants.<i>Role of coordinating centre, endpoint adjudication committee, data management team:</i> The coordinating centre is responsible for the logistical management of the orders and the follow-up of the use of the Oncogramme°, a CE-marked in vitro diagnostics medical device, developed by the French company Oncomedics, dedicated to cancer treatment decision support, the monitoring of the inclusions, and the communication with the associated centres. This trial does not require a steering committee because the number of stakeholders is limited. The Adjudication Committee is composed of 3 experts in the field of oncology and digestive surgery who did not participate in the study. The role of this committee is to determine whether or not the deaths of the included patients are attributable to the disease. The committee will make a blinded decision on the randomization arm at the end of the study.A data monitoring committee has not been set up because this is an interventional research project with minor obligations and risks (category 2)
: The promoter of the study, i.e. the University Hospital of Limoges, has access to the source data and reports of all associated centres in order to guarantee the quality of the study results.The database is created from the Ennov Clinical software. This database is hosted on a dedicated server at the Limoges University Hospital. The patient follow-up data-table of each centre can be made available to each investigator but cannot be used outside the framework of the trial.
: CL and SG are cofounders of Oncomedics SAS and have equity positions in the company. MV and CMBP are employees of Oncomedics SAS. MM, NC, MO, NT, AT, RM, IH and AT as well as the ONCOGRAM trial investigators declare that they have no competing interests.
