A model protocol evaluating the introduction of genetic assessment for women with a family history of breast cancer

Randomised controlled trials allow comparisons to be made between different models of service delivery, but have not been used in the field of clinica l genetics. With the advent of clinical governance, the evidence provided b y such trials will be increasingly important in informing and shaping clini cal genetics practice. The TRACE project (Trial of genetic assessment in br east cancer) is a randomised controlled trial of genetic assessment for wom en who are at increased risk of breast cancer because of their family histo ry. The absence of cancer genetics service provision in Wales before this s tudy gave a window of opportunity in which this important trial could be co nducted. The present paper describes how TRACE will provide crucial evidenc e regarding the psychosocial as well as resource implications of adding ind ividualised genetic assessment, genetic counselling, and (where appropriate ) gene testing to typical advice and surveillance fi om a hospital breast c linic. In addition, it is anticipated that TRACE will represent a model for future trials of service delivery in the increasing number of complex gene tic disorders where evidence on the economic implications of screening and management is currently limited.