Συσχέτιση του ιού των ανθρωπίνων θηλωμάτων με επιδημιολογικούς, κλινικομορφολογικούς και μοριακούς παράγοντες στον καρκίνο του μαστού

Ο καρκίνος του μαστού είναι ο συχνότερος καρκίνος στις γυναίκες. Τα τελευταία χρόνια, με την ανάπτυξη της μοριακής τεχνολογίας, όλο περισσότεροι παθοφυσιολογικοί μηχανισμοί έχουν κατανοηθεί και ταυτοποιηθεί, που σχετίζονται είτε με την εμφάνιση είτε με τα κλινικά και μορφολογικά χαρακτηριστικά του καρκίνου του μαστού. Οι ιοί γενικά έχουν ενοχοποιηθεί για καρκινογένεση. Ο πιο μελετημένος ιός που αποδεδειγμένα είναι ογκογόνος είναι ο ιός των ανθρωπίνων θηλωμάτων. Τα τελευταία χρόνια έχουν δημοσιευθεί πολλές μελέτες που προσπάθησαν να συσχετίσουν τον ιό με τον καρκίνο του μαστού, όμως μέχρι σήμερα τα αποτελέσματα τους είναι αντικρουόμενα. Ο στόχος της παρούσας έρευνας είναι να μελετήσει την πιθανή συσχέτιση του HPV με τον καρκίνο του μαστού, δίνοντας έμφαση τόσο στη μέθοδο συλλογής όσο και στην τεχνική επεξεργασία του δείγματος, ώστε να περιοριστεί όσο το δυνατόν η πιθανότητα επιμόλυνσης και τα ψευδώς θετικά αποτελέσματα. Στο πλαίσιο αυτό, η συλλογή του δείγματος έγινε από την ερευνήτρια στο αποστειρωμένο πεδίο του χειρουργείου και η επεξεργασία του υλικού για την ανίχνευση του HPV έγινε με τη χρήση των μικροσυστοιχιών (micro arrays), που μέχρι σήμερα θεωρούνται μια από τις πιο αξιόπιστες και ευαίσθητες τεχνικές ανίχνευσης του ιού. Από τον Απρίλιο του 2013 έως τον Ιούνιο του 2016 εντοπίσθηκαν 201 ασθενείς που πληρούσαν τις προϋποθέσεις ένταξης στο πρωτόκολλο της έρευνας. Ο μέσος όρος ηλικίας ήταν τα 59,7 έτη. Παρά το γεγονός ότι χρησιμοποιήθηκε μια τεχνική υψηλής ευαισθησίας, δε βρέθηκε DNA από τον ιό HPV σε κανένα δείγμα από το μαστό ή το λεμφαδένα φρουρό. Ωστόσο η ανάλυσή έδειξε ότι σε ασθενείς με θετικό τραχηλικό δείγμα για HPV, υπάρχει αυξημένη πιθανότητα λοβιακού τύπου καρκίνου του μαστού με θετικούς προγεστερονικούς υποδοχείς καθώς επίσης και αυξημένη πιθανότητα να έχουν 3 με 4 θετικούς μασχαλιαίους λεμφαδένες. Σε αυτή τη μελέτη, ο συνδυασμός προσεκτικής συλλογής δειγμάτων και η χρήση τεχνικής υψηλής ευαισθησίας δεν αν έδειξε συσχέτιση μεταξύ του ιού των ανθρωπίνων θηλωμάτων (HPV)και καρκίνου του μαστού. Παρ’ όλα αυτά, ορισμένα χαρακτηριστικά των καρκίνων του μαστού ήταν διαφορετικά μεταξύ των ασθενών με παρουσία HPV DNA στα τραχηλικά τους δείγματα.Human papilloma virus (HPV) is a well-known causative factor that has been implicated in several types of epithelial cancers, mainly cervical. During the last decades more and more studies associate HPV with breast cancer. Despite the fact that the number of studies has increased over the last two decades, no firm conclusions have been reached. Many researchers develop theories about the possible mechanisms that HPV can infect breast tissue and there role in carcinogenesis or in breast cancer prognosis. But, so far, there are controversial reports regarding the role of HPV in breast cancer. The aim of this study was to detect the prevalence of HPV in breast cancer, normal adjacent tissue and axillary lymphnodes using a microarray technique, and to investigate not only the possible association between breast cancer and HPV infection, but also a possible synchronous breast and cervical infection. In the present prospective study, 201 breast cancer patients were included. During the operation, under sterile conditions, two samples were collected, one from the tumor and one from the healthy adjacent tissue. The samples were deposited in two containers with preservative liquid (ThinPrep®). In patients with positive sentinel nodes, one extra sample was collected from the lymph node. In addition, for each patient a cervical sample was collected in a liquid based cytology container. All the samples were analyzed for HPV DNA with microarray technique. From the data analysis no direct implication of HPV on breast cancer was found neither in cancer nor healthy tissue or lymphnodes. However, among patients with known HPV infection, the morphological and histological characteristics of breast cancer were significantly different compared to patients without HPV infection

A Fourth Party Energy Provider for the Construction Value Chain: Identifying Needs and Establishing Requirements

Today’s building and energy management market is heterogeneous and complex. Most of the players in the construction market are not in possession of the managerial capability to fully control the dynamics that affect their energy costs in terms of energy sourcing and energy management. Moreover, construction industry needs to rely on a stronger technical and commercial expertise. On one hand, there is a need of an in-depth and extensive level of technical know-how that most of facility managers, property developers and building owners at private and public level scarcely hold. On the other hand, this industry is characterized by a fragmentation within the single tiers of the value chain. In this context, the paper aims at proposing a new vision of the building value chain towards a collaborative network led by a new player, namely the Fourth Party Energy Provider, acting as the “one-stop contracting and managing” operator, integrating resources, capabilities, best available technologies and practices for providing energy-efficient building solutions

Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document. The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003–2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues. In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product's toxicological profile. Recurring issues related to specific novel food categories were noted. The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made

Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document. The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003-2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues. In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product's toxicological profile. Recurring issues related to specific novel food categories were noted. The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made

Safety of Lemna minor and Lemna gibba whole plant material as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on Lemna minor and Lemna gibba whole plant material as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Lemna minor and Lemna gibba are aquatic plants commonly named water lentils. The NF is produced by cultivation of Lemna minor and Lemna gibba plants, washing with water and heat treatment. The main constituents of the NF are water, protein and fibre. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as a vegetable, similar to other leafy vegetables. The target population is the general population. The Panel considers that, with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that the risk that the consumption of the NF may trigger allergic reactions in humans is low. The Panel concludes that the NF, in consideration of its proposed uses and the concentration of manganese as compared to the normally present concentration of manganese in other leafy vegetables, may be of safety concern, therefore, the safety of the NF cannot currently be established

Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on Wolffia globosa powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Wolffia globosa is an aquatic plant, one out of the 38 species of the water lentil family which is composed by five genera (i.e. Spirodela, Landoltia, Lemna, Wolffiella and Wolffia). The NF is produced by cultivation of Wolffia globosa plants under controlled conditions, washing with hot water and drying. The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as food ingredient in a variety of food categories and as food supplement. The target population is the general population except for food supplements which are intended to be consumed exclusively by adults. The Panel considers that with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The subchronic toxicity study provided with the NF revealed a number of significant findings and the Panel considers the middle dose (6.5 g/kg body weight (bw) per day) as the no observed adverse effect level (NOAEL). Based on the protein concentration, the Panel considers that the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established

Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tetrahydrocurcuminoids are derivatives of curcuminoids, produced chemically by hydrogenation of curcuminoids extracted from the rhizomes of C. longa L. The NF consists of more than 95% of tetrahydrocurcuminoids. The applicant proposed to use the NF in food supplements at a maximum dose of 300 mg/day for adults excluding pregnant and lactating women. Taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study and a reproduction/developmental toxicity screening test performed with the NF, the Panel derives a safe level of 2 mg/kg body weight per day. For the target population this level corresponds to 140 mg/day, which is lower than the use level as proposed by the applicant. The Panel concludes that the NF, tetrahydrocurcuminoids from turmeric (C. longa L.), is safe for the target population at 140 mg/day

Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%-2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90-day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day

Safety of Lemna minor and Lemna gibba whole plant material as a novel food pursuant to Regulation (EU) 2015/2283.

Requestor: European Commission Question number: EFSA-Q-2020-00512 Correspondence: [email protected] reviewedPublisher PD

Safety of water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentil protein concentrate is produced from two water lentil species (L. gibba and L. minor) by separation of the protein fraction of the plant material from fibres, followed by pasteurisation and spray drying. The NF consists mainly of protein, fibre, fat and ash. The applicant proposed to use the NF as a food ingredient in a variety of food categories and as a food supplement. The target population is the general population when used as a food ingredient and exclusively adults when used as a food supplement. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. The Panel considers that the risk of the NF triggering allergic reactions is low. The Panel concludes that the NF, water lentil protein concentrate from a mixture of L. gibba and L. minor, is safe under the proposed conditions of use