title: Establishing a large prospective clinical cohort in people with head and neck cancer as a biomedical resource: head and neck 5000.
abstract: BACKGROUND
  Head and neck cancer is an important cause of ill health. Survival appears to be improving but the reasons for this are unclear. They could include evolving aetiology, modifications in care, improvements in treatment or changes in lifestyle behaviour. Observational studies are required to explore survival trends and identify outcome predictors.
  
  
  METHODS
  We are identifying people with a new diagnosis of head and neck cancer. We obtain consent that includes agreement to collect longitudinal data, store samples and record linkage. Prior to treatment we give participants three questionnaires on health and lifestyle, quality of life and sexual history. We collect blood and saliva samples, complete a clinical data capture form and request a formalin fixed tissue sample. At four and twelve months we complete further data capture forms and send participants further quality of life questionnaires.
  
  
  CONCLUSIONS
  This large clinical cohort of people with head and neck cancer brings together clinical data, patient-reported outcomes and biological samples in a single co-ordinated resource for translational and prognostic research.
authors.affiliation: National Institute for Health Research (NIHR) Biomedical Research Unit in Nutrition, Diet and Lifestyle at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol and School of Oral and Dental Sciences, University of Bristol, Bristol, UK. Andy.Ness@bristol.ac.uk.
authors.forename: Andrew Robert
authors.initials: AR
authors.lastname: Ness
authors.forename: Andrea
authors.initials: A
authors.lastname: Waylen
authors.forename: Katrina
authors.initials: K
authors.lastname: Hurley
authors.forename: Mona
authors.initials: M
authors.lastname: Jeffreys
authors.forename: Chris
authors.initials: C
authors.lastname: Penfold
authors.forename: Miranda
authors.initials: M
authors.lastname: Pring
authors.forename: Sam
authors.initials: S
authors.lastname: Leary
authors.forename: Christine
authors.initials: C
authors.lastname: Allmark
authors.forename: Stu
authors.initials: S
authors.lastname: Toms
authors.forename: Susan
authors.initials: S
authors.lastname: Ring
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Peters
authors.forename: Will
authors.initials: W
authors.lastname: Hollingworth
authors.forename: Helen
authors.initials: H
authors.lastname: Worthington
authors.forename: Chris
authors.initials: C
authors.lastname: Nutting
authors.forename: Sheila
authors.initials: S
authors.lastname: Fisher
authors.forename: Simon N
authors.initials: SN
authors.lastname: Rogers
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Thomas
mesh_terms: D003625:Data Collection; D006258:Head and Neck Neoplasms / Q000097:blood* / Q000628:therapy*; D006801:Humans; D007258:Informed Consent; D008019:Life Style; D008137:Longitudinal Studies; D008498:Medical Record Linkage; D018579:Patient Selection; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D012725:Sexual Behavior; D011795:Surveys and Questionnaires; D057170:Translational Research, Biomedical; D006113:United Kingdom