Responsabilidad del investigador en los ensayos clínicos de bajo nivel de intervención bajo el nuevo reglamento europeo 536/2014

El nuevo Reglamento Europeo sobre ensayos clínicos ha venido a crear los ensayos de bajo nivel de intervención. Se trata de una modalidad específica que ayudará a los centros de investigación de menor tamaño a realizar actividades propias, a un menor coste y con unos trámites burocráticos más cómodos. Dentro de estos ensayos, la figura del investigador se erige en central, como coordinador de la labor de investigación; siendo, por tanto, el objetivo principal en una eventual reclamación de responsabilidad legal por daños causados a participantes. Tras ofrecer un análisis general tanto de la nueva modalidad de ensayos como de los sujetos intervinientes en un ensayo clínico, analizaremos la responsabilidad del investigador en esta nueva modalidad de inn

A logistic model for the detection of circulating tumour cells in human metastatic colorectal cancer

The accuracy in the diagnosis of metastatic colorectal cancer (mCRC) represents one of the challenges in the clinical management of patients. The detection of circulating tumour cells (CTC) is becoming a promising alternative to current detection techniques, as it focuses on one of the players of the metastatic disease and it should provide with more specific and sensitive detection rates. Here, we describe an improved method of detection of CTC from mCRC patients by combining immune-enrichment, optimal purification of RNA from very low cell numbers, and the selection of accurate PCR probes. As a result, we obtained a logistic model that combines GAPDH and VIL1 normalized to CD45 rendering powerful results in the detection of CTC from mCRC patients (AUROC value 0.8599). We further demonstrated the utility of this model at the clinical setting, as a reliable prognosis tool to determine progression-free survival in mCRC patients. Overall, we developed a strategy that ameliorates the specificity and sensitivity in the detection of CTC, resulting in a robust and promising logistic model for the clinical management of metastatic colorectal cancer patients.Ministerio de Sanidad, Consumo y Bienestar Social. Beca número: CP08/00142Programa Comisión Europea Fondo Europeo de Desarollo Regional (FEDER

Impact of HER2 status in resected gastric or gastroesophageal junction adenocarcinoma in a Western population

Background: HER2 status is a predictive biomarker of response to trastuzumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. However, there is relatively little known about the role of HER2 in resected gastric or GEJ adenocarcinoma in the Western population. Methods: Retrospective, observational, single centre study of patients with gastric or GEJ adenocarcinoma undergoing surgery with curative intent between January 2007 and June 2014 in the University Hospital Complex of Santiago de Compostela. The expression of HER2 was determined by immunohistochemistry (IHC) using DAKO-HercepTest and gene amplification with DuoCISH using a DAKO-DuoCISH kit. The study of HER2 expression and amplification was carried out in all the patients and it was correlated with classic clinicopathological parameters, survival and recurrence pattern. Results: 106 patients were included. HER2 expression was as follows: 71.7% HER2 negative, 21.7% HER2 equivocal and 6.6% HER2 positive, or with HER2 overexpression. 13.2% of patients (14/106) had HER2 amplification by DuoCISH. A significant association was seen between overexpression and amplification of HER2 (p < 0.001).HER2 positivity was associated with the intestinal subtype (p = 0.010) and a low grade of differentiation (p = 0.018). Likewise, HER2 was significantly associated with a worse prognosis: overall survival (OS) 32.3 months HER2 positive versus 93.9 months HER2 negative (HR 0.42; confidence interval 95% 0.18-0.93; p = 0.028); and the presence of distant metastasis without accompanying locoregional recurrence (p = 0.048). Conclusion: HER2 status defines a subgroup with differentiated clinicopathological characteristics, worse prognosis and distant dissemination, without accompanying locoregional recurrence, in patients with resected gastric or GEJ adenocarcinoma operated on in a Western population