Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management.

Biobanks are key research infrastructures aimed at the collection, storage, processing, and sharing of high-quality human biological samples and associated data for research, diagnosis, and personalized medicine. The Biobank for Translational and Digital Medicine Unit at the European Institute of Oncology (IEO) is a landmark in this field. Biobanks collaborate with clinical divisions, internal and external research groups, and industry, supporting patients' treatment and scientific progress, including innovative diagnostics, biomarker discovery, and clinical trial design. Given the central role of biobanks in modern research, biobanking standard operating procedures (SOPs) should be extremely precise. SOPs and controls by certified specialists ensure the highest quality of samples for the implementation of science-based, diagnostic, prognostic, and therapeutic personalized strategies. However, despite numerous efforts to standardize and harmonize biobanks, these protocols, which follow a strict set of rules, quality controls, and guidelines based on ethical and legal principles, are not easily accessible. This paper presents the biobank standard operating procedures of a large cancer center.

Standard operating procedures for biobank in oncology.

Biobanks are biorepositories that collect, process, store, catalog, and distribute human biological samples, and record the associated data. The role and action field of these strategic infrastructures for implementing precision medicine in translational research is continuously evolving. To ensure the optimal quality at all stages of biobanking, specific protocols are required and should be elaborated according to updated guidelines, recommendations, laws, and rules. This article illustrates the standard operating procedures, including protocols, troubleshooting, and quality controls, of a fully certified biobank in a referral Cancer Center. This model involves all clinical departments and research groups to support the dual mission of academic cancer centers, i.e. to provide high-quality care and high-quality research. All biobanking activities based on the type of biological specimens are detailed and the most tricky methodological aspects are discussed, from patients' informed consent to specimen management.

One-Year Quality of Life Trends in Early-Stage Lung Cancer Patients After Lobectomy.

Objective: Quality of Life (QoL) is an important predictor of patient's recovery and survival in lung cancer patients. The aim of the present study is to identify 1-year trends of lung cancer patients' QoL after robot-assisted or traditional lobectomy and investigate whether clinical (e.g., pre-surgery QoL, type of surgery, and perioperative complications) and sociodemographic variables (e.g., age) may predict these trends. Methods: An Italian sample of 176 lung cancer patients undergoing lobectomy completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) at the pre-hospitalization (t0), 30 days (t1), 4 months (t2), 8 months (t3), and 12 months (t4) after surgery. Sociodemographic and clinical characteristics (age, gender, perioperative complications, and type of surgery) were also collected. The individual change over time of the 15 dimensions of the EORTC QLQ-C30 and the effects of pre-surgery scores of QoL dimensions, type of surgery, perioperative complications, and age on patients' QoL after surgery were studied with the individual growth curve (IGC) models. Results: Patients had a good recovery after lobectomy: functioning subscales improved over time, while most of the symptoms became less severe over the care process. Perioperative complications, type of surgery, pre-surgery status, and age significantly affected these trends, thus becoming predictors of patients' QoL. Conclusion: This study highlights different 1-year trends of lung cancer patients' QoL. The measurement of pre- and post-surgery QoL and its clinical and sociodemographic covariables would be necessary to better investigate patients' care process and implement personalized medicine in lung cancer hospital divisions.

Dimensionality and Measurement Invariance of the Italian Version of the EORTC QLQ-C30 in Postoperative Lung Cancer Patients.

BACKGROUND: This study aims to validate and evaluate the psychometric properties and measurement invariance of the Italian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), which is a measure of quality of life (QoL) for lung cancer patients after surgery. METHODS: A total of 167 lung cancer patients completed the Italian version of the EORTC QLQ-C30 questionnaire at 30 days after they received a lobectomy. The factor structure of this scale was assessed by performing confirmatory factor analysis (CFA). Measurement invariance was evaluated by considering differential item functioning (DIF) due to age, gender, and type of surgery (i.e., robot- or not robot-assisted). RESULTS: The CFA demonstrated the validity of the factor structure of the EORTC QLQ-C30 in assessing overall health and eight distinct subscales of adverse events and functioning. Moreover, the results highlighted a minimal DIF with only trivial consequences on measurement invariance. Specifically, the DIF did not affect the mean differences of latent scores of QoL between patients undergoing robot-assisted surgery or traditional surgery. CONCLUSION: These findings supported the validity and suitability of the EORTC QLQ-C30 for the assessment of QoL in lung cancer patients of diverse ages and genders undergoing lobectomy with or without robot-assisted surgery.

Validation of the Italian version of the abbreviated expanded prostate Cancer index composite (EPIC-26) in men with prostate Cancer.

BACKGROUND: This study aims to validate and evaluate the psychometric properties and reliability of the Italian version of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26), a measure of quality of life (QoL) for prostate cancer patients. METHODS: Two hundred and eighty-four prostate cancer patients completed the Italian version of the EPIC-26 questionnaire at 45 days (T1) and 3 months (T2) after robot-assisted radical prostatectomy (RARP). Psychometric properties were evaluated using structural equation modeling: the goodness of fit of the correlated five-factor model (CFFM) for the EPIC-26 was assessed using the confirmatory factor analysis (CFA), while longitudinal invariance was conducted to assess the ability of the EPIC-26 to measure QoL construct over time. Test-retest reliability was assessed as well by considering intraclass correlations. RESULTS: At T1, the CFFM model displayed a good fit to data. Similarly, the model showed an adequate fit also at T2. Results of the reliability analysis attested the acceptable internal consistency and test-retest reliability of each dimension: all Cronbach's alphas could be classified as acceptable (i.e., above .65) except for low Cronbach's alpha for hormonal dysfunction at T1 (i.e., .638) and urinary irritation at both waves. (i.e., respectively .585 and .518). Finally, psychometric properties were invariant over time and each of the five dimensions of QoL displayed from moderate (all ICCs above .500) to good test-retest reliability (i.e. ICC for urinary incontinence = .764). CONCLUSIONS: Results of the CFA and the measurement invariance analysis demonstrated the validity of the Italian version of the EPIC-26 to assess QoL in prostate cancer patients. Its reliability and good psychometric qualities are well-supported, thus providing a valid tool to assess health-related quality of life and its change over time in prostate cancer patients.

Sexual function recovery after robot-assisted radical prostatectomy: Outcomes from an Italian referral centre and predicting nomogram.

Aims of this study were to assess sexual recovery after robotic-assisted radical prostatectomy (RARP) and to build a nomogram predicting 1-year sexual function. From May 2015 to July 2016, all patients eligible for RARP at our institution were invited to enter the study. The Expanded Prostate cancer Index Composite (EPIC) questionnaire was administered pre-operatively, then at 45 days, and at 3, 6, 9, and 12 months post-operatively. According to sexual function scores, patients were divided into four classes. Multivariate analysis was used to investigate the influence of patient- and disease-related features on sexual recovery. A total of 643 patients were included. Age was associated with baseline potency (p < .0001). Bioptic Gleason score (GS; p = .0002), American Society of Anesthesiologists (ASA) score ( = .002ASA Physical Status Classification System ) and Charlson Comorbidity Index (CCI; p = .02) were negatively associated with potency. Baseline sexual function was associated with potency recovery. A nomogram resulted from fitting a proportional odds logistic model for ordinal outcomes, with 1-year sexual function as a dependent variable and baseline sexual potency, age, body mass index (BMI), clinical stage, biopsy GS, initial prostate-specific antigen (iPSA), ASA score, and CCI as predictors. After further validation, this nomogram could be a useful tool for the pre-operative counselling.

Predicting trajectories of recovery in prostate cancer patients undergone Robot-Assisted Radical Prostatectomy (RARP).

OBJECTIVE: To identify trends of patients' urinary and sexual dysfunctions from a clinical and psychological perspective and understand whether sociodemographic and medical predictors could differentiate among patients following different one-year longitudinal trajectories. METHODS: An Italian sample of 478 prostate cancer patients undergone Robot-Assisted Radical Prostatectomy completed the EPIC-26 survey between July 2015 and July 2016 at the pre-hospitalization (T0), 45 days (T1) and 3 (T2), 6 (T3), 9 (T4), and 12 months (T5) after surgery. Sociodemographic and clinical characteristics (age, BMI, diabetes, nerve-sparing procedure) were also collected. Latent Class Growth Analysis was conducted separately for sexual dysfunction and urinary incontinence EPIC-26 subscales. The association between membership in the two longitudinal trajectories of urinary and sexual dysfunctions was assessed by considering Chi-square test and its related contingency table. RESULTS: People who have a high level of urinary incontinence at T1 are likely to have a worse recovery. Age, BMI and pre-surgical continence may affect the level of incontinence at T1 and the recovery trajectories. Patients with low and moderate sexual problems at T1 can face a moderate linear recovery, while people with high level of impotence immediately after surgery may take a longer period to solve sexual dysfunctions. Age and the pre-surgical sexual condition may impact the recovery. Finally, a great proportion of patients reported both steady problems in sexual function and constant high levels of urinary incontinence over time. CONCLUSIONS: This study highlights different categories of patients at risk who may be important to know in order to develop personalized medical pathways and predictive models in a value-based healthcare.

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

A Trust-Based Pact in Research Biobanks. From Theory to Practice.

Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy.

Poly implant prothèse asymmetrical anatomical breast implants: a product recall study.

BACKGROUND: In 2010 high rupture rates were unexpectedly found among prostheses produced by the French manufacturer Poly Implant Prothèse. Since then, several studies have been performed concerning the round implants, but there are still few data available on anatomical implants. METHODS: From 2003 to 2006 Poly Implant Prothèse implants were employed at the authors' institute for immediate or delayed reconstruction after mastectomy. All implants were anatomical and asymmetrical. In November of 2010, the authors began offering free consultation with a plastic surgeon and radiologist. Demographic data, type of reconstruction, implant lifespan, indications for implant removal, and rupture rate were recorded. RESULTS: A total of 578 women underwent postmastectomy immediate or delayed reconstruction with 658 Poly Implant Prothèse implants from 2003 to 2006 at the authors' institute. The authors explanted 409 of 443 prostheses, and 34 were explanted at other centers. Eighty-nine patients died and 120 are alive with the implants in place. The mean implant lifespan was 57.5 months, 76 ruptured implants were explanted (18.5 percent), and in 22 cases (5.4 percent), leakage of silicone gel was detected. CONCLUSIONS: Poly Implant Prothèse implant failure is to be ascribed to shell structure, although the primary safety issue concerned the gel (an industrial-grade and low-cohesive silicone). These issues produce the known rupture rates in the manufacturer's round implants. The authors' use of only anatomical and asymmetrical implants, with their more cohesive silicone gel and more rigid shell allowing a stable form and projection along with a natural feel and touch, probably reduces the rupture rate and silicone spread, although these events remain unacceptably high compared with similar products of other brands. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.