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Biospecimen science

Claire Lewis, Stephen McQuaid, Peter W Hamilton, Manuel Salto-Tellez, Darragh McArt, Jacqueline A James
Repositories containing high quality human biospecimens linked with robust and relevant clinical and pathological information are required for the discovery and validation of biomarkers for disease diagnosis, progression and response to treatment. Current molecular based discovery projects using either low or high throughput technologies rely heavily on ready access to such sample collections. It is imperative that modern biobanks align with molecular diagnostic pathology practices not only to provide the type of samples needed for discovery projects but also to ensure requirements for ongoing sample collections and the future needs of researchers are adequately addressed...
November 2016: European Journal of Cancer
K M Antony, P Hemarajata, J Chen, J Morris, C Cook, D Masalas, M Gedminas, A Brown, J Versalovic, K Aagaard
OBJECTIVE: There is a dearth of biospecimen repositories available to perinatal researchers. In order to address this need, here we describe the methodology used to establish such a resource. STUDY DESIGN: With the collaboration of, we generated an online perinatal database with 847 fields of clinical information. Simultaneously, we established a biospecimen repository of the same clinical participants. RESULTS: The demographic and clinical outcomes data are described for the first 10 000 participants enrolled...
September 15, 2016: Journal of Perinatology: Official Journal of the California Perinatal Association
María Lourdes Garza-Rodríguez, Antonio Alí Pérez-Maya, Daniela Estefanía Monsivais-Ovalle, Juan Francisco Velázquez-Vadillo, Hugo Alberto Barrera-Saldaña
A biobank facility is one of the most valuable means that academic medical organizations have to offer researchers for improving the competitiveness of their medical research. We describe the implementation of our institutional biobank. Our efforts focused on the design and equipment of work areas, staff training, quality control, bioethical and regulatory issues, generating research collaborations and developing funding strategies. We implemented an institutional biobank at the School of Medicine of the Autonomous University of Nuevo León, Mexico...
August 2016: Salud Pública de México
Amy L McGuire, Quianta Moore, Mary Majumder, Magdalena Walkiewicz, Christine M Eng, John W Belmont, Salma Nassef, Sandra Darilek, Katie Rutherford, Stacey Pereira, Steven E Scherer, V Reid Sutton, Dwayne Wolf, Richard A Gibbs, Roger Kahn, Luis A Sanchez
No abstract text is available yet for this article.
September 2016: Genome Research
Rodney C Haring, Whitney Ann Henry, Maui Hudson, Elisa M Rodriguez, Maile Taualii
Biomedical research in culturally distinct communities is often a challenge. Potential barriers to participation occur because science is presented in a format that lacks cultural acknowledgement. Investigations may also fail to showcase beneficial relevance to the communities or include them in true partnership. The history of biomedical research within Native American societies has been complicated by these issues. Historical trauma among many Native groups sometimes transcends into contemporary challenges in both recruitment to and participation particularly in biobanking research...
July 9, 2016: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
Mats G Hansson, Lochmüller Hanns, Riess Olaf, Schaefer Franz, Orth Michael, Rubinstein Yaffa, Molster Caron, Hugh Dawkins, Taruscio Domenica, Posada Manuel, Woods Simon
There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders...
May 25, 2016: European Journal of Human Genetics: EJHG
Fay Betsou, Alexandre Bulla, Sang Yun Cho, Judith Clements, Rodrigo Chuaqui, Domenico Coppola, Yvonne De Souza, Annemieke De Wilde, William Grizzle, Fiorella Guadagni, Elaine Gunter, Stacey Heil, Verity Hodgkinson, Joseph Kessler, Michael Kiehntopf, Hee Sung Kim, Iren Koppandi, Katheryn Shea, Rajeev Singh, Marc Sobel, Stella Somiari, Demetri Spyropoulos, Mars Stone, Gunnel Tybring, Klara Valyi-Nagy, Gert Van den Eynden, Lalita Wadhwa
This technical report presents quality control (QC) assays that can be performed in order to qualify clinical biospecimens that have been biobanked for use in research. Some QC assays are specific to a disease area. Some QC assays are specific to a particular downstream analytical platform. When such a qualification is not possible, QC assays are presented that can be performed to stratify clinical biospecimens according to their biomolecular quality.
April 5, 2016: Biopreservation and Biobanking
Shuji Ogino, Reiko Nishihara, Tyler J VanderWeele, Molin Wang, Akihiro Nishi, Paul Lochhead, Zhi Rong Qian, Xuehong Zhang, Kana Wu, Hongmei Nan, Kazuki Yoshida, Danny A Milner, Andrew T Chan, Alison E Field, Carlos A Camargo, Michelle A Williams, Edward L Giovannucci
Molecular pathology diagnostics to subclassify diseases based on pathogenesis are increasingly common in clinical translational medicine. Molecular pathological epidemiology (MPE) is an integrative transdisciplinary science based on the unique disease principle and the disease continuum theory. While it has been most commonly applied to research on breast, lung, and colorectal cancers, MPE can investigate etiologic heterogeneity in non-neoplastic diseases, such as cardiovascular diseases, obesity, diabetes mellitus, drug toxicity, and immunity-related and infectious diseases...
July 2016: Epidemiology
Jonas J Astrin, Fay Betsou
Biobanks have become indispensable tools for a wide array of life and environmental sciences, and biotechnology. To evaluate trends in biobanking, 20,000 bibliographic records were retrieved and analyzed between 1939 and 2014 from the Scopus database using a series of biobank-related search terms within titles and keywords. Since the 1990s, the field of biobanking has been, and still is, experiencing above-average growth in terms of publications, journals, and thematic orientations. Almost two-thirds of all indexed biobanking documents have been published in the last decade, with now >1,000 publications in 600 distinct journals per year...
February 2016: Biopreservation and Biobanking
Roman Siddiqui, Sebastian Claudius Semler
It is accepted worldwide that biospecimen and data sharing (BDS) play an essential role for the future of medical research to improve diagnostics and prognostics, e.g. by validated biomarkers. BDS is also pivotal to the development of new therapeutic treatments and for the improvement of population health. Human biobanks can generate an added value to this need by providing biospecimens and/or associated data to researchers. An inspection of several examples of epidemiological as well as clinical/disease-oriented biobanks in Germany shows that best practice procedures (BPP) that are internationally agreed on are being installed for biospecimen and/or data access...
March 2016: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Nicole J Mitchell, Ronald T Riley, Patricia A Egner, John D Groopman, Felicia Wu
Exposure to aflatoxin, a mycotoxin common in maize and groundnuts, has been associated with childhood stunting in sub-Saharan Africa. In an effort to further our understanding of growth impairment in relation to mycotoxins and other risk factors, biospecimens from a cohort of children enrolled in the Bhaktapur, Nepal MAL-ED study were assessed for aflatoxin exposure at 15, 24, and 36 months of age. Exposure was assessed through a well-established serum biomarker, the AFB1-lysine adduct. In this manuscript, the levels of aflatoxin exposure in the Nepal cohort were compared with those observed in aflatoxin studies, with child growth parameters as a health outcome...
January 6, 2016: Journal of Exposure Science & Environmental Epidemiology
Patricia Deverka, Donna A Messner, Robert McCormack, Gary H Lyman, Margaret Piper, Linda Bradley, David Parkinson, David Nelson, Mary Lou Smith, Louis Jacques, Tania Dutta, Sean R Tunis
PURPOSE: Enthusiasm for molecular diagnostic (MDx) testing in oncology is constrained by the gaps in required evidence regarding its impact on patient outcomes (clinical utility (CU)). This effectiveness guidance document proposes recommendations for the design and evaluation of studies intended to reflect the evidence expectations of payers, while also reflecting information needs of patients and clinicians. METHODS: Our process included literature reviews and key informant interviews followed by iterative virtual and in-person consultation with an expert technical working group and an advisory group comprising life-sciences industry experts, public and private payers, patients, clinicians, regulators, researchers, and other stakeholders...
August 2016: Genetics in Medicine: Official Journal of the American College of Medical Genetics
Suzanne M Rivera, Aaron Goldenberg, Beth Rosenthal, Heide Aungst, Karen J Maschke, Erin Rothwell, Rebecca A Anderson, Jeffrey Botkin, Steven Joffe
To advance scientific knowledge about human diseases and effective therapeutic treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators' efforts to share biospecimens and data within and across institutions. Although a number of studies have explored experiences and attitudes of study participants and others about biospecimen and data sharing, less is known about investigators' perspectives. We conducted an electronic survey to learn about investigators' experiences and attitudes about research with biospecimens and associated data...
December 2015: Journal of Empirical Research on Human Research Ethics: JERHRE
Maher A Sughayer, Lina Souan
King Hussein Cancer (KHCC) is a specialized cancer center that treats both adult and pediatric cancer patients from Jordan and the neighboring countries. KHCC is acknowledged as a leader in cancer treatment in the Middle East and its vision is to maintain its leading position in cancer therapy and research. Hence, KHCC embarked on establishing the first ISO compliant cancer biobank (KHCCBIO) in Jordan.Currently, there are very few biobanks in the Middle East, hence, KHCC wanted to change this situation by establishing an ISO-compliant cancer biobank which would incorporate all current international guidelines and best-in class practices under an approved quality management system for the benefit of researchers in Jordan, its neighboring countries, and throughout the world...
2015: Advances in Experimental Medicine and Biology
Cathy D Meade, Elisa M Rodriguez, Mariana Arevalo, John S Luque, Narseary Harris, Gloria San Miguel, Clement K Gwede, Deborah O Erwin
BACKGROUND: This article describes community-engaged processes employed by two Community Network Program Center (CNPC) sites located in Tampa, Florida, and Buffalo, New York, toward the development of Spanish/English educational products about biobanking and biospecimen research. METHODS: Each CNPC carried out a community-based participatory research (CBPR) approach that underscored six essential components that moved concepts to a final educational product in a highly participatory fashion...
2015: Progress in Community Health Partnerships: Research, Education, and Action
Aaron J Goldenberg, Karen J Maschke, Steven Joffe, Jeffrey R Botkin, Erin Rothwell, Thomas H Murray, Rebecca Anderson, Nicole Deming, Beth F Rosenthal, Suzanne M Rivera
BACKGROUND: As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented. METHODS: This paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens...
2015: BMC Medical Ethics
Akram Ghantous, Hector Hernandez-Vargas, Graham Byrnes, Terence Dwyer, Zdenko Herceg
Recent advances in laboratory sciences hold a promise for a 'leap forward' in understanding the aetiology of complex human diseases, notably cancer, potentially providing an evidence base for prevention. For example, remarkable advances in epigenomics have an important impact on our understanding of biological phenomena and importance of environmental stressors in complex diseases. Environmental and lifestyle factors are thought to be implicated in the development of a wide range of human cancers by eliciting changes in the epigenome...
November 2015: Mutagenesis
Sheri D Schully, Danielle M Carrick, Leah E Mechanic, Sudhir Srivastava, Garnet L Anderson, John A Baron, Christine D Berg, Jennifer Cullen, Eleftherios P Diamandis, V Paul Doria-Rose, Katrina A B Goddard, Susan E Hankinson, Lawrence H Kushi, Eric B Larson, Lisa M McShane, Richard L Schilsky, Steven Shak, Steven J Skates, Nicole Urban, Barnett S Kramer, Muin J Khoury, David F Ransohoff
Validation of early detection cancer biomarkers has proven to be disappointing when initial promising claims have often not been reproducible in diagnostic samples or did not extend to prediagnostic samples. The previously reported lack of rigorous internal validity (systematic differences between compared groups) and external validity (lack of generalizability beyond compared groups) may be effectively addressed by utilizing blood specimens and data collected within well-conducted cohort studies. Cohort studies with prediagnostic specimens (eg, blood specimens collected prior to development of clinical symptoms) and clinical data have recently been used to assess the validity of some early detection biomarkers...
April 2015: Journal of the National Cancer Institute
Edna Mora, James A Robb, Gustavo Stefanoff, Robert Hunter Mellado, Domenico Coppola, Teresita Muñoz-Antonia, Idhaliz Flores
The 1st Puerto Rico Biobanking Workshop took place on August 20st, 2014 in the Auditorium of the Comprehensive Cancer Center of the University of Puerto Rico, Medical Sciences Campus in San Juan Puerto Rico. The program for this 1-day, live workshop included lectures by three biobanking experts, followed by presentations from existing biobanks in Puerto Rico and audience discussion. The need for increasing biobanking expertise in Puerto Rico stems from the fact that Hispanics in general are underrepresented in the biobanks in existence in the US, which limits the research conducted specifically to understand the molecular differences in cancer cells compared to other better studied populations...
2014: Reviews on Recent Clinical Trials
Monique Albert, John Bartlett, Randal N Johnston, Brent Schacter, Peter Watson
BACKGROUND: The pre-eminent goal of biobanks is to accelerate scientific discovery and support improvements in healthcare through the supply of high quality biospecimens to enable excellent science. Despite the need for retrospective future-proofed cancer repositories, they are presented with significant fiscal challenges. While it was once thought that biobanks could recover most, if not all, operational costs through distribution fees, biobanks have been consistently unable to fully realize this dream...
December 2014: Biopreservation and Biobanking
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