Abstract
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.
Highlights
DiscussionThe REFRACT-LYMA Cohort Study is the first prospective cohort of patients with Mantle Cell Lymphoma (MCL) for whom “real-life” medical, epidemiological and quality of life (QOL) data is repeatedly collected together with biological samples during the course of the disease
Mantle 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
To address all these limitations, we have developed a multicenter prospective cohort of patients with MCL: the REFRACT-LYMA Cohort
Summary
This is the first prospective cohort of patients with MCL where medical, epidemiological and QOL data is repeatedly collected in combination with biological samples collected before treatment initiation and at treatment failure. In the mid-term, this integrative cohort will be a unique data source enabling each MCL patient to conceive the most effective personal therapy according to a large variety of data (patient tumor biological characteristics, epidemiological data, patient medical history, QOL measures and ex-vivo functional assays). The REFRACT-LYMA Cohort will answer health and pharmacoeconomic questions about the medical care of MCL patients using “real-life data”, as opposed to clinical trials. The REFRACT-LYMA Cohort is designed to facilitate collaboration with investigators, institutions, cooperative groups and pharmaceutical companies working in the MCL area
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