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British Journal of Cancer Aug 2017Endometrial cancer is the most common gynaecological cancer and its incidence is predicted to escalate by 50-100% in 2025 with a parallel increase in associated...
BACKGROUND
Endometrial cancer is the most common gynaecological cancer and its incidence is predicted to escalate by 50-100% in 2025 with a parallel increase in associated mortality. Variations in the collection, processing and storage of biospecimens can affect the generalisability of the scientific data. We aimed to harmonise the collection of biospecimens, clinical data relevant to endometrial cancer and to develop standard operative procedures for the collection, processing and storage of endometrial cancer biospecimens.
METHODS
We designed research tools, which were evaluated and revised through three consensus rounds - to obtain local/regional, national and European consensus. Modified final tools were disseminated to a panel (n=40) representing all stakeholders in endometrial cancer research for consensus generation.
RESULTS
The final consensus demonstrated unanimous agreement with the minimal surgical and patient data collection tools. A high level of agreement was also observed for the other remaining standard tools.
CONCLUSIONS
We here present the final versions of the tools, which are freely available and easily accessible to all endometrial cancer researchers. We believe that these tools will facilitate rapid progress in endometrial cancer research, both in future collaborations and in large-scale multicentre studies.
Topics: Biomedical Research; Consensus; Endometrial Neoplasms; Female; Guidelines as Topic; Humans; Specimen Handling; Surveys and Questionnaires; Tissue Banks
PubMed: 28664917
DOI: 10.1038/bjc.2017.194 -
International Journal of Hygiene and... Jun 2021Characterizing the complexity of environmental exposures in relation to human health is critical to advancing our understanding of health and disease throughout the life... (Review)
Review
BACKGROUND
Characterizing the complexity of environmental exposures in relation to human health is critical to advancing our understanding of health and disease throughout the life span. Extant cohort studies open the door for such investigations more rapidly and inexpensively than launching new cohort studies and the Human Health Exposure Analysis Resource (HHEAR) provides a resource for implementing life-stage exposure studies within existing study populations. Primary challenges to incorporation of environmental exposure assessment in health studies include: (1) lack of widespread knowledge of biospecimen and environmental sampling and storage requirements for environmental exposure assessment among investigators; (2) lack of availability of and access to laboratories capable of analyzing multiple environmental exposures throughout the life-course; and (3) studies lacking sufficient power to assess associations across life-stages. HHEAR includes a consortium of researchers with expertise in laboratory analyses, statistics and logistics to overcome these limitations and enable inclusion of exposomics in human health studies.
OBJECTIVE
This manuscript describes the structure and strengths of implementing the harmonized HHEAR resource model, and our approaches to addressing challenges. We describe how HHEAR incorporates analyses of biospecimens and environmental samples and human health studies across the life span - serving as a model for incorporating environmental exposures into national and international research. We also present program successes to date.
DISCUSSION
HHEAR provides a full-service laboratory and data analysis exposure assessment resource, linking scientific, life span, and toxicological consultation with both laboratory and data analysis expertise. HHEAR services are provided without cost but require NIH, NCI, NHLBI, or ECHO funding of the original cohort; internal HHEAR scientific review and approval of a brief application; and adherence to data sharing and publication policies. We describe the benefits of HHEAR's structure, collaborative framework and coordination across project investigators, analytical laboratories, biostatisticians and bioinformatics specialists; quality assurance/quality control (QA/QC) including integrated sample management; and tools that have been developed to support the research (exposure information pages, ontology, new analytical methods, common QA/QC approach across laboratories, etc.). This foundation supports HHEAR's inclusion of new laboratory and statistical analysis methods and studies that are enhanced by including targeted analysis of specific exposures and untargeted analysis of chemicals associated with phenotypic endpoints in biological and environmental samples.
CONCLUSION
HHEAR is an interdisciplinary team of toxicologists, epidemiologists, laboratory scientists, and data scientists across multiple institutions to address broad and complex questions that benefit from integrated laboratory and data analyses. HHEAR's processes, features, and tools include all life stages and analysis of biospecimens and environmental samples. They are available to the wider scientific community to augment studies by adding state of the art environmental analyses to be linked to human health outcomes.
Topics: Environmental Exposure; Environmental Health; Exposome; Health Resources; Humans; Research Design
PubMed: 34034040
DOI: 10.1016/j.ijheh.2021.113768 -
Current Pathobiology Reports 2018Precision medicine promises patient tailored, individualized diagnosis and treatment of diseases and relies on clinical specimen integrity and accuracy of companion... (Review)
Review
PURPOSE OF REVIEW
Precision medicine promises patient tailored, individualized diagnosis and treatment of diseases and relies on clinical specimen integrity and accuracy of companion diagnostic testing. Therefore, pre-analytics, which are defined as the collection, processing, and storage of clinical specimens, are critically important to enable optimal diagnostics, molecular profiling, and clinical decision-making around harvested specimens. This review article discusses the impact of tumor pre-analytics on molecular pathology focusing on biospecimen protein expression and analysis.
RECENT FINDINGS
Due to busy clinical schedules and workflows that have been established for many years and to lack of standardization and limited assessment tools to quantify variability in pre-analytical processing, the effects of pre-analytics on biospecimen integrity are often overlooked. Several studies have recently emphasized an emerging crisis in science and reproducibility of results.
SUMMARY
Biomarker instability due to pre-analytical variables affects comprehensive analysis and molecular phenotyping of patients' tissue. This problematic emphasizes the critical need for standardized protocols and technologies to be applied in the clinical and research setting.
PubMed: 30595971
DOI: 10.1007/s40139-018-0179-5 -
Frontiers in Medicine 2022There is ongoing and increasing interest in the commercialization of biospecimen-derived products from Indigenous Peoples. Discourse on benefit-sharing specifically in... (Review)
Review
BACKGROUND
There is ongoing and increasing interest in the commercialization of biospecimen-derived products from Indigenous Peoples. Discourse on benefit-sharing specifically in the context of the commercialization of Indigenous Peoples biospecimens are currently lacking. A better understanding of the potential ethical imperatives is in need of exploration on this emerging topic. This review sought to elucidate through categorization the current discourse in the peer-reviewed literature on the commercialization of Indigenous Peoples' biospecimens from a benefit-sharing perspective.
METHODS
A scoping review methodology was utilized to perform a search of PubMed, CINAHL, Embase and Google Scholar. A two-stage screening process was used to assess the relevance of any included articles with subsequent manual open coding of articles. Content analysis was applied to identify the main categories and sub-categories within the article data.
RESULTS
articles met the inclusion criteria for analysis. Four overarching categories from the included articles were identified regarding the most common discourse on the commercialization of Indigenous Peoples' biospecimens from a benefit-sharing perspective, including: exploitation through biocolonialism, sovereignty and Indigenous rights, ethical considerations for benefit-sharing, and guidelines and standards concerns.
CONCLUSION
This scoping review highlighted the crucial need to keep Indigenous communities at the center of research projects, ensuring any benefits, advancement, and potential commercial profits are returned to communities through clear and ethical agreements. We encourage all research institutions and institutional ethical review bodies to better clarify the collective needs and interests of Indigenous communities while centering their sovereignty and rights within the research process as it pertains to potential biospecimen product commercialization.
PubMed: 35991662
DOI: 10.3389/fmed.2022.978826 -
PloS One 2022The aim of this article is to provide a detailed description of the Golden Retriever Lifetime Study (GRLS), a prospective cohort study investigating nutritional,...
The aim of this article is to provide a detailed description of the Golden Retriever Lifetime Study (GRLS), a prospective cohort study investigating nutritional, environmental, lifestyle, and genetic risk factors for cancer and other common diseases in dogs. Primary outcomes of interest include hemangiosarcoma, lymphoma, osteosarcoma, and high-grade mast cell tumors. Secondary outcomes of interest include other cancers, hypothyroidism, epilepsy, atopy, otitis externa, hip dysplasia, heart failure, and renal failure. A total of 3,044 United States Golden Retrievers aged 6 months to 2 years completed baseline enrollment from June 2012 to April 2015. As of May 31, 2021, 2,251 dogs remain engaged in the study, 352 have died, and 441 are lost to follow-up. Extensive annual questionnaires completed by owners and veterinarians gather information about lifestyle, environmental exposures, physical activity, reproductive history, behavior, diet, medications, and diagnoses. Dogs also have annual veterinary examinations and biospecimen collection (blood, serum, hair, nails, feces, urine) for biobanking. Additional reporting, including histology and tumor biobanking, is conducted for any malignancies or deaths. When an animal dies, full medical records are obtained, and necropsies are requested at owner discretion. Full or partial necropsies have been performed on 218 dogs. Questionnaire data are freely available to researchers with approved credentials who agree to a data use agreement. In addition, researchers can submit proposals to utilize biospecimens or obtain additional data.
Topics: Animals; Biological Specimen Banks; Cohort Studies; Dog Diseases; Dogs; Female; Hemangiosarcoma; Humans; Prospective Studies; United States
PubMed: 35679242
DOI: 10.1371/journal.pone.0269425 -
Biopreservation and Biobanking Jun 2021Human biological specimen (biospecimen) donation is routinely requested for clinical care and research purposes. Successfully engaging patients and research...
Human biological specimen (biospecimen) donation is routinely requested for clinical care and research purposes. Successfully engaging patients and research participants in biospecimen donation depends on what they understand these initiatives entail, including their perceptions of risk. Human biospecimens are stored in facilities routinely referenced as biobanks or biorepositories, both of which labels are known to embody a variety of connotations. The words chosen to describe biospecimen facilities may influence decisions about donation. To explore differences in likelihood of donation as a function of the words chosen to represent human biospecimen storage facilities and the commensurate concerns each label evokes. Two-group experimental design. Participants completed a survey about a fictitious undertaking requesting that they consider biospecimen donation. The term used to describe the facility housing the biospecimens differed; one half of the surveys referenced a biobank, and one half referenced a biorepository. Two thousand five hundred ninety-six surveys were distributed; 586 completed surveys were received (response rate: 22.6%). Sixty-three percent of respondents, regardless of whether the label referenced a biobank or biorespository, reported being extremely likely to donate. There were no significant differences between the 2 groups on the 11 concerns sampled. Factor analyses revealed that concerns could be classified in two groups: use-related concerns and person-related concerns. The label biobank evoked significantly lower perception of importance of the person-related concerns sampled (e.g., personal or other benefit, discomfort or inconvenience). Our results suggest that researchers may consider using the word biobank to describe the facility housing the biospecimen, as this term appears less subject to concern biases. These outcomes confirm that misunderstandings or misattributions of words used to refer to biospecimen facilities could deter participation in clinical care or research. Participation may be enhanced through ensuring clear understanding of what biospecimen donation entails and by directly addressing common semantic misunderstandings and associations.
Topics: Adolescent; Adult; Biological Specimen Banks; Female; Humans; Male; Middle Aged; Research Personnel; Semantics; Specimen Handling; Surveys and Questionnaires; Young Adult
PubMed: 33179960
DOI: 10.1089/bio.2020.0072 -
Frontiers in Public Health 2024There is an urgent need for increased understanding of COVID-19 and strategies for its prevention, treatment, and mitigation. All participants in the research... (Review)
Review
There is an urgent need for increased understanding of COVID-19 and strategies for its prevention, treatment, and mitigation. All participants in the research enterprise, including institutional review boards, have an ethical duty to protect participants and ensure that the benefits gained from such research do not conflict with the core principles that guided researchers prior to the pandemic. In this review, we discuss the ethical issues surrounding initiation and conduct of clinical trials, focusing on novel COVID-19 therapeutic, vaccine, or biospecimen research, using the principles of autonomy, beneficence, and justice. We discuss strategies to manage the practical challenges associated with the conduct of clinical trials, with an emphasis on maintaining the rights and welfare of research participants.
Topics: Humans; COVID-19; Ethics Committees, Research; COVID-19 Vaccines
PubMed: 38510356
DOI: 10.3389/fpubh.2024.1359654 -
Frontiers in Public Health 2020Biobanks have become integral to improving population health. We are in a new era in medicine as patients, health professionals, and researchers increasingly collaborate... (Review)
Review
Biobanks have become integral to improving population health. We are in a new era in medicine as patients, health professionals, and researchers increasingly collaborate to gain new knowledge and explore new paradigms for diagnosing and treating disease. Many large-scale biobanking efforts are underway worldwide at the institutional, national, and even international level. When linked with subject data from questionnaires and medical records, biobanks serve as valuable resources in translational research. A biobank must have high quality samples that meet researcher's needs. Biobank laboratory operations require an enormous amount of support-from lab and storage space, information technology expertise, and a laboratory management information system to logistics for sample movement, quality management systems, and appropriate facilities. A paramount metric of success for a biobank is the concept of every biospecimen coming to the repository belongs to a participant who has something to contribute to research for a healthier future. This article will discuss the importance of biorepository operations, specific to the collection and storage of participants materials. Specific focus will be given to maintaining the quality of samples, along with the various levels of support biorepositories need to fulfill their purpose and ensure the integrity of each specimen is maintained.
Topics: Biological Specimen Banks; Humans; Laboratories; Research Personnel; Translational Research, Biomedical
PubMed: 32850593
DOI: 10.3389/fpubh.2020.00362 -
The Journal of Allergy and Clinical... Apr 2018Because asthma is a disease that results from host-environment interactions, an approach that allows assessment of the effect of the environment on the host is needed to... (Review)
Review
Because asthma is a disease that results from host-environment interactions, an approach that allows assessment of the effect of the environment on the host is needed to understand the disease. Metabolomics has appealing potential as an application to study pathways to childhood asthma development. The objective of this review is to provide an overview of metabolomics methods and their application to understanding host-environment pathways in asthma development. We reviewed recent literature on advances in metabolomics and their application to study pathways to childhood asthma development. We highlight the (1) potential of metabolomics in understanding the pathogenesis of disease and the discovery of biomarkers; (2) choice of metabolomics techniques, biospecimen handling, and data analysis; (3) application to studying the role of the environment on asthma development; (4) review of metabolomics applied to the outcome of asthma; (5) recommendations for application of metabolomics-based -omics data integration in understanding disease pathogenesis; and (6) limitations. In conclusion, metabolomics allows use of biospecimens to identify useful biomarkers and pathways involved in disease development and subsequently to inform a greater understanding of disease pathogenesis and endotypes and prediction of the clinical course of childhood asthma phenotypes.
Topics: Asthma; Biomarkers; Child; Environment; Environmental Exposure; Humans; Metabolome; Metabolomics; Research Design; Risk Factors
PubMed: 28479327
DOI: 10.1016/j.jaci.2017.04.021 -
Developmental Cognitive Neuroscience Aug 2018Biospecimen collection in the Adolescent Brain Cognitive Development (ABCD) study - of hair samples, shed deciduous (baby) teeth, and body fluids - will serve dual... (Review)
Review
Biospecimen collection in the Adolescent Brain Cognitive Development (ABCD) study - of hair samples, shed deciduous (baby) teeth, and body fluids - will serve dual functions of screening for study eligibility, and providing measures of biological processes thought to predict or correlate with key study outcomes on brain and cognitive development. Biosamples are being collected annually to screen for recency of drug use prior to the neuroimaging or cognitive testing visit, and to store for the following future studies: (1) on the effects of exposure to illicit and recreational drugs (including alcohol and nicotine); (2) of pubertal hormones on brain and cognitive developmental trajectories; (3) on the contribution of genomics and epigenomics to child and adolescent development and behavioral outcomes; and (4) with pre- and post-natal exposure to environmental neurotoxicants and drugs of abuse measured from novel tooth analyses. The present manuscript describes the rationales for inclusion and selection of the specific biospecimens, methodological considerations for each measure, future plans for assessment of biospecimens during follow-up visits, and preliminary ABCD data to illustrate methodological considerations.
Topics: Adolescent; Adolescent Development; Brain; Child; Cognition; Female; Humans; Neuroimaging; Specimen Handling
PubMed: 29606560
DOI: 10.1016/j.dcn.2018.03.005