The REFRACT-LYMA cohort study: a French observational prospective cohort study of patients with mantle cell lymphoma

BMC Cancer

Study Protocol

Matthieu Hanf¹  Sophie de Visme¹  Steven le Gouill²  David Chiron³  Martine Amiot⁴  Cyrille Touzeau⁴  Catherine Pellat-Deceunynck⁴  Hervé Maisonneuve⁵  Henry Jardel⁶ 

[1]INSERM CIC 1413, Centre Hospitalier Universitaire de Nantes, Nantes, France

[2]INSERM CIC 1413, Centre Hospitalier Universitaire de Nantes, Nantes, France

[3]INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France

[4]Service d’Hématologie Clinique, Unité d’Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France

[5]CHU de Nantes, Place Alexis Ricordeau, 44000, Nantes, France

[6]INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France

[7]INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France

[8]Service d’Hématologie Clinique, Unité d’Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France

[9]Service de Médecine Onco-hématologie, Centre Hospitalier Départemental de La Roche sur Yon, La Roche sur Yon, France

[10]Service de Médecine interne - Maladies hématologiques - Maladies infectieuses, Centre Hospitalier Bretagne Atlantique, Vannes, France

关键词: Cancer;    Mantle cell lymphoma;    Cohort;    Therapeutic failure;    Biological samples;    Functional assays;    Quality of life;    Epidemiology;    Pharmacoeconomics;   

DOI  :  10.1186/s12885-016-2844-6

 received in 2015-11-03, accepted in 2016-10-06,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundMantle Cell Lymphoma (MCL) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MCL is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MCL therapies and about associated predictors remains poor. The REFRACT-LYMA Cohort, a multicenter prospective cohort of patients with MCL, is set up to address this limitation. We here describe the study background, design and methods used for this cohort.Methods/DesignThe REFRACT-LYMA Cohort Study aims at including all patients (>18 years old) who are diagnosed with MCL in any stage of the disease and treated in specialized oncology centers in three public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up indefinitely, until refusal to participate in the study, emigration or death. The REFRACT-LYMA follow-up is continuous and collects data on socio-economic status, medical status, MCL therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.DiscussionTo our knowledge, the REFRACT-LYMA Cohort Study is the first prospective cohort of patients with MCL for whom “real-life” medical, epidemiological and QOL data is repeatedly collected together with biological samples during the course of the disease. The integrative cohort at mid-term will be unique at producing a large variety of data that can be used to conceive the most effective personalized therapy for MCL patients. Additionally, the REFRACT-LYMA Cohort puts the medical care of MCL patients in a health and pharmacoeconomic perspective.

【 授权许可】

CC BY   
© The Author(s). 2016