Hervé Ghesquières1, Cédric Rossi2, Fanny Cherblanc3, Sandra Le Guyader-Peyrou4, Fontanet Bijou5, Pierre Sujobert6, Pascale Fabbro-Peray7, Adeline Bernier3, Aurélien Belot3, Loic Chartier3, Luc-Matthieu Fornecker8, Isabelle Baldi4, Krimo Bouabdallah9, Camille Laurent10, Lucie Oberic11, Nadine Morineau12, Steven Le Gouill13, Franck Morschhauser14, Corinne Haioun15, Gandhi Damaj16, Stéphanie Guidez17, Gaëlle Labouré18, Olivier Fitoussi19, Laure Lebras20, Rémy Gressin21, Gilles Salles6, Loïc Ysebaert11, Alain Monnereau4. 1. Hospices Civils de Lyon, Lyon Sud Hospital, 165 Chemin du Grand Revoyet, 69310, Pierre-Bénite, France. herve.ghesquieres@chu-lyon.fr. 2. CHU Dijon, 10 Boulevard Maréchal De Lattre De Tassigny, 21000, Dijon, France. 3. LYSARC, 165 Chemin du Grand Revoyet, 69310, Pierre-Bénite, France. 4. Inserm U1219 - EPICENE team, Université de Bordeaux, Bordeaux, France. 5. Bergonié Institute, 229 Cours de l'Argonne, 33076, Bordeaux, France. 6. Hospices Civils de Lyon, Lyon Sud Hospital, 165 Chemin du Grand Revoyet, 69310, Pierre-Bénite, France. 7. CHU Nîmes, 4 Rue du Professeur Robert Debré, 30029, Nîmes, France. 8. Cancerology Institute Strasbourg Europe, Avenue Molière, BP 428, 67098, Strasbourg, France. 9. CHU Bordeaux, Avenue Magellan, 33604, Bordeaux, France. 10. Toulouse Research Center in Cancerology, 2 Avenue Hubert Curien, 31037, Toulouse, France. 11. IUCT Oncopole, 1 Avenue Irène Joliot Curie, 31100, Toulouse, France. 12. CHD Vendée, Boulevard Stéphane Moreau, 85000, La Roche-sur-Yon, France. 13. CHU Nantes, 1 place Alexis Ricordeau, 44093, Nantes, France. 14. CHRU Lille, Rue Michel Polonovski, 59037, Lille, France. 15. Henri Mondor Hospital, 51 Avenue du Maréchal de Lattre de Tassigny, 94010, Créteil, France. 16. Hematology Institute of Basse Normandie, 6 Avenue Côte de Nacre, 14033, Caen, France. 17. CHU Poitiers, 2 rue de la Milétrie, 86021, Poitiers, France. 18. CH Libourne, 112 Rue de la Marne, 33500, Libourne, France. 19. Polyclinique Bordeaux Nord Aquitaine, 15-35 Rue Claude Boucher, 33300, Bordeaux, France. 20. Léon Bérard Center, 28 rue Laennec, 69008, Lyon, France. 21. CHU Grenoble, Bd de la Chantourne BP 217, 38043, Grenoble, France.
Abstract
BACKGROUND: Age-adjusted lymphoma incidence rates continue to rise in France since the early 80's, although rates have slowed since 2010 and vary across subtypes. Recent improvements in patient survival in major lymphoma subtypes at population level raise new questions about patient outcomes (i.e. quality of life, long-term sequelae). Epidemiological studies have investigated factors related to lymphoma risk, but few have addressed the extent to which socioeconomic status, social institutional context (i.e. healthcare system), social relationships, environmental context (exposures), individual behaviours (lifestyle) or genetic determinants influence lymphoma outcomes, especially in the general population. Moreover, the knowledge of the disease behaviour mainly obtained from clinical trials data is partly biased because of patient selection. METHODS: The REALYSA ("REal world dAta in LYmphoma and Survival in Adults") study is a real-life multicentric cohort set up in French areas covered by population-based cancer registries to study the prognostic value of epidemiological, clinical and biological factors with a prospective 9-year follow-up. We aim to include 6000 patients over 4 to 5 years. Adult patients without lymphoma history and newly diagnosed with one of the following 7 lymphoma subtypes (diffuse large B-cell, follicular, marginal zone, mantle cell, Burkitt, Hodgkin, mature T-cell) are invited to participate during a medical consultation with their hematologist. Exclusion criteria are: having already received anti-lymphoma treatment (except pre-phase) and having a documented HIV infection. Patients are treated according to the standard practice in their center. Clinical data, including treatment received, are extracted from patients' medical records. Patients' risk factors exposures and other epidemiological data are obtained at baseline by filling out a questionnaire during an interview led by a clinical research assistant. Biological samples are collected at baseline and during treatment. A virtual tumor biobank is constituted for baseline tumor samples. Follow-up data, both clinical and epidemiological, are collected every 6 months in the first 3 years and every year thereafter. DISCUSSION: This cohort constitutes an innovative platform for clinical, biological, epidemiological and socio-economic research projects and provides an opportunity to improve knowledge on factors associated to outcome of lymphoma patients in real life. TRIAL REGISTRATION: 2018-A01332-53, ClinicalTrials.gov identifier: NCT03869619 .
BACKGROUND: Age-adjusted lymphoma incidence rates continue to rise in France since the early 80's, although rates have slowed since 2010 and vary across subtypes. Recent improvements in patient survival in major lymphoma subtypes at population level raise new questions about patient outcomes (i.e. quality of life, long-term sequelae). Epidemiological studies have investigated factors related to lymphoma risk, but few have addressed the extent to which socioeconomic status, social institutional context (i.e. healthcare system), social relationships, environmental context (exposures), individual behaviours (lifestyle) or genetic determinants influence lymphoma outcomes, especially in the general population. Moreover, the knowledge of the disease behaviour mainly obtained from clinical trials data is partly biased because of patient selection. METHODS: The REALYSA ("REal world dAta in LYmphoma and Survival in Adults") study is a real-life multicentric cohort set up in French areas covered by population-based cancer registries to study the prognostic value of epidemiological, clinical and biological factors with a prospective 9-year follow-up. We aim to include 6000 patients over 4 to 5 years. Adult patients without lymphoma history and newly diagnosed with one of the following 7 lymphoma subtypes (diffuse large B-cell, follicular, marginal zone, mantle cell, Burkitt, Hodgkin, mature T-cell) are invited to participate during a medical consultation with their hematologist. Exclusion criteria are: having already received anti-lymphoma treatment (except pre-phase) and having a documented HIV infection. Patients are treated according to the standard practice in their center. Clinical data, including treatment received, are extracted from patients' medical records. Patients' risk factors exposures and other epidemiological data are obtained at baseline by filling out a questionnaire during an interview led by a clinical research assistant. Biological samples are collected at baseline and during treatment. A virtual tumor biobank is constituted for baseline tumor samples. Follow-up data, both clinical and epidemiological, are collected every 6 months in the first 3 years and every year thereafter. DISCUSSION: This cohort constitutes an innovative platform for clinical, biological, epidemiological and socio-economic research projects and provides an opportunity to improve knowledge on factors associated to outcome of lymphoma patients in real life. TRIAL REGISTRATION: 2018-A01332-53, ClinicalTrials.gov identifier: NCT03869619 .
Entities:
Keywords:
Cohort study; France; Lymphoma patients; Outcomes; Real life
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