title: A model protocol evaluating the introduction of genetic assessment for women with a family history of breast cancer.
abstract: Randomised controlled trials allow comparisons to be made between different models of service delivery, but have not been used in the field of clinical genetics. With the advent of clinical governance, the evidence provided by such trials will be increasingly important in informing and shaping clinical genetics practice. The TRACE project (Trial of genetic assessment in breast cancer) is a randomised controlled trial of genetic assessment for women who are at increased risk of breast cancer because of their family history. The absence of cancer genetics service provision in Wales before this study gave a window of opportunity in which this important trial could be conducted. The present paper describes how TRACE will provide crucial evidence regarding the psychosocial as well as resource implications of adding individualised genetic assessment, genetic counselling, and (where appropriate) gene testing to typical advice and surveillance from a hospital breast clinic. In addition, it is anticipated that TRACE will represent a model for future trials of service delivery in the increasing number of complex genetic disorders where evidence on the economic implications of screening and management is currently limited.
authors.affiliation: Institute of Medical Genetics, University of Wales College of Medicine, Heath Park, Cardiff CF4 4XN, UK.
authors.forename: J
authors.initials: J
authors.lastname: Gray
authors.forename: K
authors.initials: K
authors.lastname: Brain
authors.forename: P
authors.initials: P
authors.lastname: Norman
authors.forename: C
authors.initials: C
authors.lastname: Anglim
authors.forename: L
authors.initials: L
authors.lastname: France
authors.forename: G
authors.initials: G
authors.lastname: Barton
authors.forename: L
authors.initials: L
authors.lastname: Branston
authors.forename: E
authors.initials: E
authors.lastname: Parsons
authors.forename: A
authors.initials: A
authors.lastname: Clarke
authors.forename: J
authors.initials: J
authors.lastname: Sampson
authors.forename: E
authors.initials: E
authors.lastname: Roberts
authors.forename: R
authors.initials: R
authors.lastname: Newcombe
authors.forename: D
authors.initials: D
authors.lastname: Cohen
authors.forename: C
authors.initials: C
authors.lastname: Rogers
authors.forename: R
authors.initials: R
authors.lastname: Mansel
authors.forename: P
authors.initials: P
authors.lastname: Harper
mesh_terms: D000328:Adult; D024682:BRCA2 Protein; D001943:Breast Neoplasms / Q000235:genetics*; D005069:Evaluation Studies as Topic; D005260:Female; D019398:Genes, BRCA1; D005817:Genetic Counseling; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D006801:Humans; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000235:genetics; D018570:Risk Assessment; D014157:Transcription Factors / Q000235:genetics
chemical_list: D024682:BRCA2 Protein; D009363:Neoplasm Proteins; D014157:Transcription Factors