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2.
BMJ Open ; 11(9): e045239, 2021 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-34475143

RESUMO

INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.


Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mastectomia , Mamilos/cirurgia
4.
Cell Rep Methods ; 1(2): 100011, 2021 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-34235498

RESUMO

We have developed a rapid, accurate, and cost-effective serologic test for SARS-CoV-2 virus, which caused the COVID-19 pandemic, on the basis of antibody-dependent agglutination of antigen-coated latex particles. When validated using plasma samples that are positive or negative for SARS-CoV-2, the agglutination assay detected antibodies against the receptor-binding domain of the spike (S-RBD) or the nucleocapsid protein of SARS-CoV-2 with 100% specificity and ∼98% sensitivity. Furthermore, we found that the strength of the S-RBD antibody response measured by the agglutination assay correlated with the efficiency of the plasma in blocking RBD binding to the angiotensin-converting enzyme 2 in a surrogate neutralization assay, suggesting that the agglutination assay might be used to identify individuals with virus-neutralizing antibodies. Intriguingly, we found that >92% of patients had detectable antibodies on the day of a positive viral RNA test, suggesting that the agglutination antibody test might complement RNA testing for the diagnosis of SARS-CoV-2 infection.

5.
JCI Insight ; 6(13)2021 07 08.
Artigo em Inglês | MEDLINE | ID: mdl-34081630

RESUMO

BACKGROUNDThe role of humoral immunity in COVID-19 is not fully understood, owing, in large part, to the complexity of antibodies produced in response to the SARS-CoV-2 infection. There is a pressing need for serology tests to assess patient-specific antibody response and predict clinical outcome.METHODSUsing SARS-CoV-2 proteome and peptide microarrays, we screened 146 COVID-19 patients' plasma samples to identify antigens and epitopes. This enabled us to develop a master epitope array and an epitope-specific agglutination assay to gauge antibody responses systematically and with high resolution.RESULTSWe identified linear epitopes from the spike (S) and nucleocapsid (N) proteins and showed that the epitopes enabled higher resolution antibody profiling than the S or N protein antigen. Specifically, we found that antibody responses to the S-811-825, S-881-895, and N-156-170 epitopes negatively or positively correlated with clinical severity or patient survival. Moreover, we found that the P681H and S235F mutations associated with the coronavirus variant of concern B.1.1.7 altered the specificity of the corresponding epitopes.CONCLUSIONEpitope-resolved antibody testing not only affords a high-resolution alternative to conventional immunoassays to delineate the complex humoral immunity to SARS-CoV-2 and differentiate between neutralizing and non-neutralizing antibodies, but it also may potentially be used to predict clinical outcome. The epitope peptides can be readily modified to detect antibodies against variants of concern in both the peptide array and latex agglutination formats.FUNDINGOntario Research Fund (ORF) COVID-19 Rapid Research Fund, Toronto COVID-19 Action Fund, Western University, Lawson Health Research Institute, London Health Sciences Foundation, and Academic Medical Organization of Southwestern Ontario (AMOSO) Innovation Fund.


Assuntos
Testes de Aglutinação/métodos , Formação de Anticorpos/imunologia , Teste Sorológico para COVID-19/métodos , COVID-19/imunologia , Epitopos de Linfócito B/imunologia , SARS-CoV-2/imunologia , Sequência de Aminoácidos , Anticorpos Neutralizantes/sangue , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , Especificidade de Anticorpos/imunologia , COVID-19/sangue , COVID-19/mortalidade , Epitopos/imunologia , Epitopos de Linfócito B/química , Epitopos de Linfócito B/genética , Humanos , Imunidade Humoral , Análise em Microsséries/métodos , Nucleocapsídeo/química , Nucleocapsídeo/genética , Nucleocapsídeo/imunologia , Peptídeos/imunologia , SARS-CoV-2/genética , Índice de Gravidade de Doença , Glicoproteína da Espícula de Coronavírus/química , Glicoproteína da Espícula de Coronavírus/genética , Glicoproteína da Espícula de Coronavírus/imunologia
6.
Front Pediatr ; 9: 669453, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34055700

RESUMO

Renal infarction is a rare finding in children. Associations between SARS-CoV-2 infections and thromboembolic events including renal infarcts have been described in adults. Although a similar association in children has not yet been described with this pandemic, the pediatric literature is still evolving with the recognition of new manifestations including the post-infectious Multisystem Inflammatory Syndrome in Children (MIS-C). We report the rare event of multiple renal infarcts in a 6-year-old boy manifesting several features of MIS-C 9 weeks following a self-limiting febrile illness characteristic of COVID-19. An underlying Factor V Leiden mutation was identified in this child but felt to be insufficient on its own to explain his clinical presentation. As SARS-CoV-2 testing was delayed, the failure to identify viral RNA or antibodies may not exclude the virus' potential role in precipitating the infarct in this host. Given that renal infarcts have been described in adult patients with COVID-19, reporting this perplexing case where SARS-CoV-2 may have played a role, may help identify this potential complication.

8.
Clin Biochem ; 95: 1-12, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34048776

RESUMO

OBJECTIVES: A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. DESIGN AND METHODS: The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT. RESULTS AND CONCLUSIONS: Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight.


Assuntos
COVID-19/diagnóstico , Consenso , Testes Imediatos/normas , Guias de Prática Clínica como Assunto/normas , SARS-CoV-2/isolamento & purificação , Sociedades Científicas/normas , COVID-19/epidemiologia , COVID-19/genética , Canadá/epidemiologia , Humanos , Pesquisa Qualitativa , Melhoria de Qualidade/normas , SARS-CoV-2/genética
10.
Eur J Breast Health ; 17(2): 188-196, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33870120

RESUMO

Objective: In early 2020, the spread of coronavirus disease-2019 (COVID-19) led the World Health Organization to declare this disease a pandemic. Initial epidemiological data showed that patients with cancer were at high risk of developing severe forms of COVID-19. National scientific societies published recommendations modifying the patients' breast cancer (BC) management to preserve, in theory, quality oncologic care, avoiding the increased risk of contamination. The Senology International Society (SIS) decided to take an inventory of the actions taken worldwide. This study investigates COVID-19-related changes concerning BC management and analyzes the will to maintain them after the pandemic, evaluating their oncological safety consequences. Materials and Methods: SIS network members participated in an online survey using a questionnaire (Microsoft® Forms) from June 15th to July 31st, 2020. Results: Forty-five responses from 24 countries showed that screening programs had been suspended (68%); magnetic resonance imagines were postponed (73%); telemedicine was preferred when possible (71%). Surgeries were postponed: reconstructive (77%), for benign diseases (84%), and in patients with significant comorbidities (66%). Chemotherapy and radiotherapy protocols had been adapted in 28% of patients in both. Exception for telemedicine (34%), these changes in practice should not be continued. Conclusion: The SIS survey showed significant changes in BC's diagnosis and treatment during the first wave of the COVID-19 pandemic, but most of these changes should not be maintained. Indeed, women have fewer severe forms of COVID-19 and are less likely to die than men. The risk of dying from COVID-19 is more related to the presence of comorbidities and age than to BC. Stopping screening and delaying treatment leads to more advanced stages of BC. Only women aged over 65 with BC under treatment and comorbidities require adaptation of their cancer management.

11.
Ther Umsch ; 78(3): 129-135, 2021 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-33775132

RESUMO

Inpatient treatment of Breast Cancer - the essentials Abstract. The treatment of breast cancer patients in the inpatient setting has dramatically changed over the last decades. Modern operative techniques resulted in tremendous reductions of morbidity and complication rates. New breast conserving surgical techniques and the consequent reduction of unnecessary extensive lymph node surgery resulted in a significantly shorter length of stay. This in combination with the system of lump compensations and diagnosis related groups (DRG) led to the fact that the inpatient treatment is just another part of a complex multidisciplinary diagnostic and therapeutic algorithm. Most of the steps are being organized and performed in the outpatient setting. The overall effort has increased nevertheless due to modern quality standards and certification of breast centers.


Assuntos
Neoplasias da Mama , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/cirurgia , Grupos Diagnósticos Relacionados , Hospitalização , Humanos , Pacientes Internados , Pacientes Ambulatoriais
12.
ACS Appl Mater Interfaces ; 13(7): 8745-8753, 2021 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-33560117

RESUMO

Ceramic fibers are high-tech structural key components of ceramic matrix composites (CMCs), which are a very promising class of materials for applications in next-generation turbines, especially nonoxide ceramic fibers, usually produced by the polymer-derived ceramics (PDC) route, which possess the enhanced mechanical and thermostructural properties necessary to withstand the harsh conditions (temperature and atmosphere) imposed on CMCs. However, recycling composite materials, such as fiber-reinforced polymers and CMCs, is still a big challenge. Here, we present for the first time the processing of superparamagnetic iron-containing ceramic fibers, which, due to their magnetic properties, can be separated from the matrix material of a composite. The synthesis strategy of the novel functional ceramic fibers is based on a tailored reaction of polyorganosilazane with an iron complex, resulting in a suitable, meltable polymer. After melt-spinning and curing, subsequent pyrolysis leads to superparamagnetic ceramic fibers with a saturation magnetization of 1.54 emu g-1 because of in situ-formed iron silicide nanoparticles of an average size of 7.5 nm, homogeneously dispersed in an amorphous SiCNO matrix. Moreover, the ceramic fibers exhibit a tensile strength of 1.24 GPa and appropriate oxidation resistance. The developed versatile reaction strategy allows also for the incorporation of other elements to implement further functionalities for processing of multifunctional composites.

13.
Lancet Oncol ; 22(1): e18-e28, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33387500

RESUMO

Primary systemic therapy is increasingly used in the treatment of patients with early-stage breast cancer, but few guidelines specifically address optimal locoregional therapies. Therefore, we established an international consortium to discuss clinical evidence and to provide expert advice on technical management of patients with early-stage breast cancer. The steering committee prepared six working packages to address all major clinical questions from diagnosis to surgery. During a consensus meeting that included members from European scientific oncology societies, clinical trial groups, and patient advocates, statements were discussed and voted on. A consensus was reached in 42% of statements, a majority in 38%, and no decision in 21%. Based on these findings, the panel developed clinical guidance recommendations and a toolbox to overcome many clinical and technical requirements associated with the diagnosis, response assessment, surgical planning, and surgery of patients with early-stage breast cancer. This guidance could convince clinicians and patients of the major clinical advancements purported by primary systemic therapy, the use of less extensive and more targeted surgery to improve the lives of patients with breast cancer.


Assuntos
Antineoplásicos/administração & dosagem , Neoplasias da Mama/terapia , Mastectomia Segmentar/normas , Oncologia/normas , Terapia Neoadjuvante/normas , Antineoplásicos/efeitos adversos , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Tomada de Decisão Clínica , Consenso , Técnica Delfos , Feminino , Humanos , Mastectomia Segmentar/efeitos adversos , Terapia Neoadjuvante/efeitos adversos , Estadiamento de Neoplasias , Resultado do Tratamento
14.
Surg Endosc ; 35(7): 3670-3678, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-32767145

RESUMO

BACKGROUND: AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO2 recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO2 insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO2 insufflators in patients undergoing the most frequently performed laparoscopic procedures. METHODS: One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO2 insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay. RESULTS: Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay. CONCLUSION: This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO2 insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).


Assuntos
Colecistectomia Laparoscópica , Insuflação , Laparoscopia , Pneumoperitônio , Dióxido de Carbono , Colecistectomia Laparoscópica/efeitos adversos , Humanos , Dor Pós-Operatória/epidemiologia , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controle , Pneumoperitônio Artificial/efeitos adversos , Estudos Prospectivos
15.
Clin Biochem ; 88: 11-17, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33264650

RESUMO

Point of Care Testing (POCT) refers to clinical laboratory testing performed outside the central laboratory, nearer to the patient and sometimes at the patient bedside. The testing is usually performed by clinical staff, such as physicians or nurses, who are not laboratory trained. This document was developed by the POCT Interest group of the Canadian Society of Clinical Chemists (CSCC) as practical guidance for quality assurance practices related to POCT performed in hospital and outside hospital environments. The aspects of quality assurance addressed in this document include: (1) device selection, (2) initial device verification, (3) ongoing device verification, (4) ongoing quality assurance including reagent and quality control (QC) lot changes, and (5) quality management including operator and document management.


Assuntos
Técnicas de Laboratório Clínico/normas , Testes Imediatos/normas , Garantia da Qualidade dos Cuidados de Saúde/métodos , Canadá , Humanos , Guias de Prática Clínica como Assunto/normas , Controle de Qualidade
17.
Clin Cancer Res ; 26(17): 4682-4687, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32561662

RESUMO

PURPOSE: Invasive lobular carcinoma (ILC) accounts for approximately 5%-15% of all invasive breast cancer cases. Most of the correlations between multigene assays and patient outcome were derived from studies based on patients with invasive ductal carcinoma (IDC) or without distinction between the subtypes. Here, we investigate the prognostic value of EndoPredict (EPclin) in a large cohort of ILCs pooled from three phase III randomized trials (ABCSG-6, ABCSG-8, TransATAC). EXPERIMENTAL DESIGN: The primary objective of this analysis was to determine the prognostic value of EPclin for distant recurrence (DR) in years 0-10 in postmenopausal women with ILC. The primary outcome was DR. RESULTS: 470 women (17.9%) presented with ILC, 1,944 (73.9%) with IDC, and 216 (8.2%) with other histologic types. EPclin was highly prognostic in women with ILC [HR = 3.32 (2.54-4.34)] and provided more prognostic value than the Clinical Treatment Score [CTS; HR = 2.17 (1.73-2.72)]. 63.4% of women were categorized into the low EPclin risk group and they had a 10-year DR of 4.8% (2.7-8.4) compared with 36.6% of women in the high-risk group with a 10-year DR risk of 26.6% (20.0-35.0). EPclin also provided highly prognostic information in women with node-negative disease [HR = 2.56 (1.63-4.02)] and node-positive disease [HR = 3.70 (2.49-5.50)]. CONCLUSIONS: EPclin provided highly significant prognostic value and significant risk stratification for women with ILC. Ten-year DR risk in the EPclin low-risk groups were similar between ILC and IDC. Our results show that EPclin is informative in women with ILC and suggest that it is equally valid in both histologic subtypes.

18.
Breast ; 51: 120-126, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32302928

RESUMO

OBJECTIVES: The proliferative activity of the Ki-67 index is important in decision-making of adjuvant treatments in early breast cancer. Its reliability can be reduced by inter-observer variability. This analysis' objective is to evaluate the robustness of Ki-67 values within one center over 5 years and to compare its distribution with a published dataset. MATERIALS AND METHODS: Ki-67 indices of early breast cancers treated at St. Gallen Breast Center were collected (2010-2014; 1154 patients). Distribution of Ki-67 values was analyzed for each year, along with histologic subtype and grading. Tumors were classified into intrinsic subtypes using two definitions: 2013 St. Gallen Consensus and the refined definition by Maisonneuve ("Milano Group"). Our institution's Ki-67 cut-off value was adjusted to obtain the same distribution of luminal subtypes as published data of the Milano Group. RESULTS: Ki-67 index frequency distributions were comparable between years (mean 26-30%, median 22-26%). Shape and position of the distribution curves were nearly identical. Ki-67 values correlated with tumor grade (median Ki-67: G1: 12.0%, G2: 21%, G3: 38%). Standard deviation of Ki-67 increased with higher grading (G1: 6.9; G2: 9.2; G3: 18.2; p < 0.001). According to the 2013 definition (and refined definition respectively), there were 35% (41%) luminal A-like and 65% (59%) luminal B-like tumors. To obtain the same distribution as the Milano group, Ki-67 cut-off needed to be elevated to 22%. CONCLUSIONS: Ki-67 index assessment was comparable over many years. Knowledge of one's institution's Ki-67 value distribution is essential for clinical decision-making of adjuvant therapies in early breast cancer.


Assuntos
Neoplasias da Mama/classificação , Neoplasias da Mama/patologia , Antígeno Ki-67 , Biomarcadores Tumorais , Tomada de Decisão Clínica , Feminino , Humanos , Valores de Referência , Reprodutibilidade dos Testes , Estudos Retrospectivos , Índice Terapêutico
19.
Br J Cancer ; 122(12): 1744-1746, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32336753

RESUMO

Inter-test concordance between the MammaPrint and the EndoPredict tests used to predict the risk of recurrence in breast cancer was evaluated in 94 oestrogen receptor-positive, HER2-negative breast cancers. We correlated histopathological data with clinical risk estimation as defined in the MINDACT trial. 42.6% (40/94) of cases were high-risk by MammaPrint, 44.7% (42/94) by EndoPredict (EPclin), and 45.7% (43/94) by clinical risk definition. Thirty-six percent of genomic risk predictions were discordant with a low inter-test correlation between EndoPredict and MammaPrint (p = 0.012; κ = 0.27, 95% CI [0.069, 0.46]). Clinical risk stratification did not correlate with MammaPrint (p = 0.476) but highly correlated with EndoPredict (p < 0.001). Consequently, clinically high-risk tumours (n = 43) were more frequently high-risk by EndoPredict than by MammaPrint (76.6% vs. 46.5%, p = 0.004), with 44% of cases discordantly classified and no significant association between genomic risk predictions (p = 0.294). Clinicians need to be aware that clinical pre-stratification can profoundly influence multigenomic test performance.


Assuntos
Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Perfilação da Expressão Gênica/métodos , Testes Genéticos/métodos , Recidiva Local de Neoplasia/genética , Feminino , Humanos , Medição de Risco/métodos
20.
Breast Cancer Res Treat ; 176(2): 481-482, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31152325

RESUMO

The article Second International Consensus Conference on lesions of uncertain malignant potential in the breast (B3 lesions), written by Christoph J Rageth, Elizabeth AM O'Flynn, Katja Pinker, Rahel A Kubik-Huch, Alexander Mundinger, Thomas Decker, Christoph Tausch, Florian Dammann, Pascal A. Baltzer, Eva Maria Fallenberg, Maria P Foschini, Sophie Dellas, Michael Knauer, Caroline Malhaire, Martin Sonnenschein, Andreas Boos, Elisabeth Morris, Zsuzsanna Varga, was originally published electronically on the publisher's internet portal (currently SpringerLink) on November 30, 2018 without open access.

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