title: The REFRACT-LYMA cohort study: a French observational prospective cohort study of patients with mantle cell lymphoma.
abstract: 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. 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.
  
  
  
  The 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.
  
  
  
  To 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.
authors.affiliation: INSERM CIC 1413, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Hanf
authors.affiliation: INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France.
authors.forename: David
authors.initials: D
authors.lastname: Chiron
authors.affiliation: INSERM CIC 1413, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: de Visme
authors.affiliation: INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France.|Service d'Hématologie Clinique, Unité d'Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Touzeau
authors.affiliation: Service de Médecine Onco-hématologie, Centre Hospitalier Départemental de La Roche sur Yon, La Roche sur Yon, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Maisonneuve
authors.affiliation: Service de Médecine interne - Maladies hématologiques - Maladies infectieuses, Centre Hospitalier Bretagne Atlantique, Vannes, France.
authors.forename: Henry
authors.initials: H
authors.lastname: Jardel
authors.affiliation: INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France.|Service d'Hématologie Clinique, Unité d'Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Pellat-Deceunynck
authors.affiliation: INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France.|Service d'Hématologie Clinique, Unité d'Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Amiot
authors.affiliation: INSERM CIC 1413, Centre Hospitalier Universitaire de Nantes, Nantes, France. steven.legouill@chu-nantes.fr.|INSERM, UMR892 - CNRS, UMR 6299, Université de Nantes, Nantes, France. steven.legouill@chu-nantes.fr.|Service d'Hématologie Clinique, Unité d'Investigation Clinique, Centre Hospitalier Universitaire de Nantes, Nantes, France. steven.legouill@chu-nantes.fr.|CHU de Nantes, Place Alexis Ricordeau, 44000, Nantes, France. steven.legouill@chu-nantes.fr.
authors.forename: Steven
authors.initials: S
authors.lastname: le Gouill
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D015996:Survival Rate; D055815:Young Adult
keywords: Biological samples; Cancer; Cohort; Epidemiology; Functional assays; Mantle cell lymphoma; Pharmacoeconomics; Quality of life; Therapeutic failure