Impact of rapid genetic counselling and testing on the decision to undergo immediate or delayed prophylactic mastectomy in newly diagnosed breast cancer patients: findings from a randomised controlled trial.

BACKGROUND: Female breast cancer patients with a BRCA1/2 mutation have an increased risk of contralateral breast cancer. We investigated the effect of rapid genetic counselling and testing (RGCT) on choice of surgery. METHODS: Newly diagnosed breast cancer patients with at least a 10% risk of a BRCA1/2 mutation were randomised to an intervention group (offer of RGCT) or a control group (usual care; ratio 2 : 1). Primary study outcomes were uptake of direct bilateral mastectomy (BLM) and delayed contralateral prophylactic mastectomy (CPM). RESULTS: Between 2008 and 2010, we recruited 265 women. On the basis of intention-to-treat analyses, no significant group differences were observed in percentage of patients opting for a direct BLM (14.6% for the RGCT group vs 9.2% for the control group; odds ratio (OR) 2.31; confidence interval (CI) 0.92-5.81; P=0.08) or for a delayed CPM (4.5% for the RGCT group vs 5.7% for the control group; OR 0.89; CI 0.27-2.90; P=0.84). Per-protocol analysis indicated that patients who received DNA test results before surgery (59 out of 178 women in the RGCT group) opted for direct BLM significantly more often than patients who received usual care (22% vs 9.2%; OR 3.09, CI 1.15-8.31, P=0.03). INTERPRETATION: Although the large majority of patients in the intervention group underwent rapid genetic counselling, only a minority received DNA test results before surgery. This may explain why offering RGCT yielded only marginally significant differences in uptake of BLM. As patients who received DNA test results before surgery were more likely to undergo BLM, we hypothesise that when DNA test results are made routinely available pre-surgery, they will have a more significant role in surgical treatment decisions.

Contrast-ultrasound dispersion imaging for prostate cancer localization by improved spatiotemporal similarity analysis.

Angiogenesis plays a major role in prostate cancer growth. Despite extensive research on blood perfusion imaging aimed at angiogenesis detection, the diagnosis of prostate cancer still requires systematic biopsies. This may be due to the complex relationship between angiogenesis and microvascular perfusion. Analysis of ultrasound-contrast-agent dispersion kinetics, determined by multipath trajectories in the microcirculation, may provide better characterization of the microvascular architecture. We propose the physical rationale for dispersion estimation by an existing spatiotemporal similarity analysis. After an intravenous ultrasound-contrast-agent bolus injection, dispersion is estimated by coherence analysis among time-intensity curves measured at neighbor pixels. The accuracy of the method is increased by time-domain windowing and anisotropic spatial filtering for speckle regularization. The results in 12 patient data sets indicated superior agreement with histology (receiver operating characteristic curve area = 0.88) compared with those obtained by reported perfusion and dispersion analyses, providing a valuable contribution to prostate cancer localization.

A trial of consent procedures for future research with clinically derived biological samples.

BACKGROUND: The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are. METHODS: We offered 264 cancer patients three different consent procedures: 'one-time general consent' (asked written informed consent), 'opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures. RESULTS: In all, 99% of patients consented to research with their residual tissue. In the 'one-time consent' group 85% sent back their consent form. Patients preferred 'opt-out plus' (43%) above 'one-time consent' (34%) or 'opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice. CONCLUSIONS: The 'opt-out plus' procedure, which places fewer demands on administrative resources than 'one-time consent', can also address the information needs of patients.

Opt-out plus, the patients' choice: preferences of cancer patients concerning information and consent regimen for future research with biological samples archived in the context of treatment.

AIMS: The aims of this study were to determine: (1) which consent procedures patients prefer for future medical research with tissue stored following surgery; (2) the percentage of patients who choose not to provide consent for research with their stored tissue; (3) the reasons given for denying such tissue use. METHODS: Patients (n = 103) from the Vrije Universiteit Medical Centre, an academic hospital in The Netherlands, who had recently undergone surgery for breast or colorectal cancer were mailed a questionnaire about preferences for consent regimens. RESULTS: Seventy-six patients (74%) completed the questionnaire. Only two patients (3%) chose not to provide consent for research with their stored tissue. The majority of patients (60%) preferred an "opt-out plus" procedure that included receiving active, verbal information to "one-time general consent" (11%) or to an "opt-out" procedure without verbal notification (5%). Only 3% indicated a wish to be asked for consent for each new research project and 21% did not know what they preferred or had no preference. There were no significant associations observed between preference for the various consent regimens and age, sex, educational level or personal sense of ownership of the stored tissue. CONCLUSION: Patients prefer an opt-out plus procedure that includes the provision of explicit, verbal and written information. Less than 5% of patients decline to consent to the use of their stored tissue for research purposes.