General autoimmunity

Oral

Clinical Data Specification and Coding for Cross-analyses with Omics Data in Autoimmune Diseases’ Trials

Friday, June 16
6:15 PM - 7:30 PM

Autoimmune and inflammatory diseases (AIDs) form a continuum of diseases with variable contribution of autoimmunity and inflammation. Yet, the nosography of AIDs remains mostly based on syndromic classification. The TRANSIMMUNOM observational clinical trial (NCT02466217) aims at re-evaluating AIDs nosography through multi-omics investigations of 1000 patients with one of nineteen selected AIDs. During patients' visits, clinical records and biological samples are gathered. To allow cross analyses of clinical data together with omics results, there is a need for specifying and then coding each type of data. To this end: i) a clinical expert consortium selected hundreds of relevant clinical features and clinical laboratory values to be collected for all patients, such as to homogeneously describe clinico-biological status of every patients irrespective of their disease; ii) a cohort management team, involving biologists, clinicians and computer scientists designed an electronic Case Report Form (eCRF) using an open-source CFR-part 11 compliant electronic data capture system and iii) used CDISC standards for the coding of more than 700 heterogeneous parameters. For each parameter, the values to be recorded were specified and coded. Example of such coding are Yes/No check boxes for clinical investigation, numerical values with a list of relevant units according to the parameter, disease scores as a result of the automatized sum of several scores, treatment description including the coding of possible formula, dosage and posology. Altogether, a truly multidisciplinary endeavor led to design and implement a collection of 24 CRF capturing more than 8000 coded values that are now used in TRANSIMMUNOM.

Encarnita Mariotti-Ferrandiz

Associate Professor
Sorbonne Université, UPMC Univ Paris 06, UMRS 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005, Paris, France

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    Roberta Lorenzon

    AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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      Iannis Drakos

      Sorbonne Université, UPMC Univ Paris 06, UMRS 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005, Paris, France

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        Claire Ribet

        AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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          Maeva Cordoba

          AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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            Patrice Cacoub

            APHP, Hôpital Pitié-Salpêtrière, Internal Medecine and Clinical Immunology

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              David Saadoun

              APHP, Hôpital Pitié-Salpêtrière, Internal Medecine and Clinical Immunology

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                Agnes Hartemann

                APHP, Hôpital Pitié-Salpêtrière, Diabetology, F-75651, Paris, France

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                  Bahram Bodaghi

                  APHP, Hôpital Pitié-Salpêtrière, Ophthalmology, F-75651, Paris, France

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                    Francis Berenbaum

                    APHP, Hôpital Saint-Antoine, Rheumatology Department, Inserm UMR S_938, UPMC Univ Paris 06, Paris, France

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                      Gilles Grateau

                      APHP, Hôpital Tenon, Internal Medecine, Paris, France

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                        Olivier Benveniste

                        APHP, Hôpital Pitié-Salpêtrière, Internal Medecine, Paris, France

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                          Jeremie Sellam

                          APHP, Hôpital Saint-Antoine, Rheumatology Department, Inserm UMR S_938, UPMC Univ Paris 06, Paris, France

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                            Philippe Seksik

                            APHP, Hôpital Saint-Antoine, Gastroenterology Department, Paris, France

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                              Claude Bernard

                              AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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                                Adrien Six

                                Sorbonne Université, UPMC Univ Paris 06, UMRS 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005, Paris, France

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                                  Michelle Rosenzwagj

                                  AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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                                    Caroline Aheng

                                    AP-HP, Hôpital Pitié-Salpêtrière, Biotherapy (CIC-BTi) and Inflammation-Immunopathology-Biotherapy Department (I2B), F-75651, Paris, France

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                                      David Klatzmann

                                      Sorbonne Université, UPMC Univ Paris 06, UMRS 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005, Paris, France

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                                        Clinical Data Specification and Coding for Cross-analyses with Omics Data in Autoimmune Diseases’ Trials



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