RT Journal Article SR Electronic T1 A model protocol evaluating the introduction of genetic assessment for women with a family history of breast cancer JF Journal of Medical Genetics JO J Med Genet FD BMJ Publishing Group Ltd SP 192 OP 196 DO 10.1136/jmg.37.3.192 VO 37 IS 3 A1 Gray, Jonathon A1 Brain, Kate A1 Norman, Paul A1 Anglim, Cathy A1 France, Liz A1 Barton, Garry A1 Branston, Lucy A1 Parsons, Evelyn A1 Clarke, Angus A1 Sampson, Julian A1 Roberts, Elizabeth A1 Newcombe, Robert A1 Cohen, David A1 Rogers, Cerilan A1 Mansel, Robert A1 Harper, Peter YR 2000 UL http://jmg.bmj.com/content/37/3/192.abstract AB 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.