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A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort
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. q...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927409/ https://www.ncbi.nlm.nih.gov/pubmed/33653294 http://dx.doi.org/10.1186/s12889-021-10433-4 |
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author | Ghesquières, Hervé Rossi, Cédric Cherblanc, Fanny Le Guyader-Peyrou, Sandra Bijou, Fontanet Sujobert, Pierre Fabbro-Peray, Pascale Bernier, Adeline Belot, Aurélien Chartier, Loic Fornecker, Luc-Matthieu Baldi, Isabelle Bouabdallah, Krimo Laurent, Camille Oberic, Lucie Morineau, Nadine Le Gouill, Steven Morschhauser, Franck Haioun, Corinne Damaj, Gandhi Guidez, Stéphanie Labouré, Gaëlle Fitoussi, Olivier Lebras, Laure Gressin, Rémy Salles, Gilles Ysebaert, Loïc Monnereau, Alain |
author_facet | Ghesquières, Hervé Rossi, Cédric Cherblanc, Fanny Le Guyader-Peyrou, Sandra Bijou, Fontanet Sujobert, Pierre Fabbro-Peray, Pascale Bernier, Adeline Belot, Aurélien Chartier, Loic Fornecker, Luc-Matthieu Baldi, Isabelle Bouabdallah, Krimo Laurent, Camille Oberic, Lucie Morineau, Nadine Le Gouill, Steven Morschhauser, Franck Haioun, Corinne Damaj, Gandhi Guidez, Stéphanie Labouré, Gaëlle Fitoussi, Olivier Lebras, Laure Gressin, Rémy Salles, Gilles Ysebaert, Loïc Monnereau, Alain |
author_sort | Ghesquières, Hervé |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-021-10433-4. |
format | Online Article Text |
id | pubmed-7927409 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-79274092021-03-03 A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort Ghesquières, Hervé Rossi, Cédric Cherblanc, Fanny Le Guyader-Peyrou, Sandra Bijou, Fontanet Sujobert, Pierre Fabbro-Peray, Pascale Bernier, Adeline Belot, Aurélien Chartier, Loic Fornecker, Luc-Matthieu Baldi, Isabelle Bouabdallah, Krimo Laurent, Camille Oberic, Lucie Morineau, Nadine Le Gouill, Steven Morschhauser, Franck Haioun, Corinne Damaj, Gandhi Guidez, Stéphanie Labouré, Gaëlle Fitoussi, Olivier Lebras, Laure Gressin, Rémy Salles, Gilles Ysebaert, Loïc Monnereau, Alain BMC Public Health Study Protocol 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12889-021-10433-4. BioMed Central 2021-03-02 /pmc/articles/PMC7927409/ /pubmed/33653294 http://dx.doi.org/10.1186/s12889-021-10433-4 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Ghesquières, Hervé Rossi, Cédric Cherblanc, Fanny Le Guyader-Peyrou, Sandra Bijou, Fontanet Sujobert, Pierre Fabbro-Peray, Pascale Bernier, Adeline Belot, Aurélien Chartier, Loic Fornecker, Luc-Matthieu Baldi, Isabelle Bouabdallah, Krimo Laurent, Camille Oberic, Lucie Morineau, Nadine Le Gouill, Steven Morschhauser, Franck Haioun, Corinne Damaj, Gandhi Guidez, Stéphanie Labouré, Gaëlle Fitoussi, Olivier Lebras, Laure Gressin, Rémy Salles, Gilles Ysebaert, Loïc Monnereau, Alain A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title | A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title_full | A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title_fullStr | A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title_full_unstemmed | A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title_short | A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “REal world dAta in LYmphoma and survival in adults” (REALYSA) cohort |
title_sort | french multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the “real world data in lymphoma and survival in adults” (realysa) cohort |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927409/ https://www.ncbi.nlm.nih.gov/pubmed/33653294 http://dx.doi.org/10.1186/s12889-021-10433-4 |
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