-
Pathology Oncology Research : POR Oct 2018Biobanks play an increasing role in contemporary research projects. These units meet all requirements to regard them as a one of the most innovative and up-to-date in... (Review)
Review
Biobanks play an increasing role in contemporary research projects. These units meet all requirements to regard them as a one of the most innovative and up-to-date in the field of biomedical research. They enable conducting wide-scale research by the professional collection of biological specimens and correlated clinical data. Pathology units may be perceived roots of biobanking. The review aims at describing the concept of biobanks, their model of function and scientific potential. It comprises the division of biobanks, sample preservation methods and IT solutions as well as guidelines and recommendations for management of a vast number of biological samples and clinical data. Therefore, appropriate standard operating procedures and protocols are outlined. Constant individualization of diagnostic process and treatment procedures creates the niche for translational units. Thus, the role of biobanks in personalized medicine was also specified. The exceptionality of biobanks poses some new ethical-legal issues which have various solutions, in each legal system, amongst the world. Finally, distribution and activity of European biobanks are mentioned.
Topics: Biological Specimen Banks; Biomedical Research; Humans
PubMed: 29728978
DOI: 10.1007/s12253-018-0418-4 -
Frontiers in Public Health 2022The West China Hospital of Sichuan University collaborated with regional medical consortia in Sichuan Province to launch a natural population cohort study (NPCS) to... (Review)
Review
OBJECTIVE
The West China Hospital of Sichuan University collaborated with regional medical consortia in Sichuan Province to launch a natural population cohort study (NPCS) to investigate the health status of residents and collect public health data in southwest China.
METHODS
Up to 80,000 participants will be enrolled by the NPCS from 11 regional medical consortia over five years. Individuals are invited to visit one of 11 participating medical consortia to fill out questionnaires, receive a free health exam, and donate biospecimens upon enrolment. All participating medical facilities adhered to standard operating procedures for collecting and processing biospecimens to ensure uniformity (serum, lithium heparinized plasma, ethylene diamine tetraacetie acid plasma, and buffy coat). The Electronic Data Capture System, Picture Archiving and Communication System, Laboratory Information Management System, Biospecimen Quality Control System, Biobank Information Management System, and will be used to sort and classify clinical indices, imaging data, laboratory parameters, pre-analytical variables, and biospecimen information, respectively. All quality assurance and quality control procedures in the NPCS biobank adhered to the "DAIDS Guidelines for Good Clinical Laboratory Practice Standards". This project will integrate high-dimensional multi-omics data, laboratory data, clinical data, questionnaire data, and environmental risk factors.
RESULTS
An estimated 2,240,000 aliquots of the sample will be stored by the end of the study. These samples are linked with comprehensively collected clinical indices, imaging data, and laboratory parameters. Big data analysis can be implemented to create predictive algorithms, explore pathogenesis mechanisms, uncover potential biomarkers, and provide information on public health.
CONCLUSIONS
NPCS will provide an integrative approach to research risk factors and pathogenesis of major chronic or endemic diseases in Sichuan Province and provide key scientific evidence to support the formulation of health management policies in China.
Topics: Humans; Biological Specimen Banks; Cohort Studies; Surveys and Questionnaires; Biomarkers; China
PubMed: 36530701
DOI: 10.3389/fpubh.2022.996169 -
Methods in Molecular Biology (Clifton,... 2019The personnel who operate a biomedical biobank should function as a unit to efficiently manage the numerous types of biospecimens that are to be utilized for both... (Review)
Review
The personnel who operate a biomedical biobank should function as a unit to efficiently manage the numerous types of biospecimens that are to be utilized for both clinical and research purposes. Therefore, new staff must be appropriately trained before becoming fully integrated into the work environment. This chapter focuses on several key aspects to this training that should be completed by all personnel. This first step is an orientation where the new trainee is provided with the priorities and expectations of the biobank. The next and perhaps most important step is training on the various safety precautions. The trainee should learn how to protect patient privacy if human biospecimens are involved. They should gain a basic understanding of different types of biospecimens and their vulnerabilities to suboptimal storage conditions. The trainee must learn the various aspects of the day to day work which encompasses the methods and equipment needed for procuring, labeling, handling, tracking, storing, disbursing, and shipping biospecimens. They should become familiar with aspects of quality assurance.
Topics: Biological Specimen Banks; Humans; Specimen Handling
PubMed: 30539434
DOI: 10.1007/978-1-4939-8935-5_6 -
BMJ Open Dec 2022Obtaining ecologically valid biological samples is critical for understanding respiratory effects of tobacco use, but can be burdensome. In two diverse samples, we... (Observational Study)
Observational Study
OBJECTIVE
Obtaining ecologically valid biological samples is critical for understanding respiratory effects of tobacco use, but can be burdensome. In two diverse samples, we examined feasibility and acceptability of studying pulmonary function and respiratory health entirely remotely.
DESIGN
Observational feasibility and acceptability study.
SETTING AND PARTICIPANTS
Adults age 18-25 (Biomedical Respiratory Effects Associated through Habitual Use of E-Cigarettes [BREATHE] Study) and 21-65 (Adult IQOS Respiratory [AIRS] Study) recruited from previous research studies and advertisements in Southern California, USA (BREATHE (AIRS): N=77 (N=31) completed baseline, n=64 (n=20) completed feasibility and acceptability measures). Shared inclusion criteria for the two studies were ownership of a smartphone, willingness to download applications and English fluency. In addition, BREATHE participants reported one of three tobacco use patterns. AIRS participants smoked daily and were willing to use a heated tobacco product. Exclusion criteria were medical contraindications.
INTERVENTIONS
A 4-week study consisted of five virtual study visits, twice daily ecological momentary assessment diaries and spirometry assessments, and weekly Nasal Epithelial Lining Fluid and saliva collection. All study visits were conducted via video conference; study materials and biospecimens were exchanged via mail. Participants reported feasibility and acceptability of daily diaries, breath tests, biospecimen collection and shipments.
MEASURES
Surveys assessed perceptions of timing and overall experience of daily diaries and breath tests, difficulty of and overall experience with biospecimen collection, and experience sending and receiving shipments.
RESULTS
Most participants evaluated daily diaries and breath tests as manageable (62.5%-95.0%) and likeable (54.7%-70.0%). Breath tests were frequently described as 'interesting' (55.0%-57.8%) and 'easy' (25.0%-48.4%). Most participants reported that biospecimen collection was easy (50.0%-85.0%), and that shipments were easy to send (87.5%-95.0%), receive (95.3%-95.0%) and schedule (56.3%-60.0%). No participants received shipments in poor condition.
CONCLUSIONS
Remote research procedures may be feasible and acceptable to facilitate tobacco research studies, potentially resulting in more diverse samples of participants and more generalisable research results.
Topics: Adult; Humans; Adolescent; Young Adult; Electronic Nicotine Delivery Systems; Feasibility Studies; Tobacco Use; Respiratory System; Nicotiana; Tobacco Products
PubMed: 36456013
DOI: 10.1136/bmjopen-2022-065962 -
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 -
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 -
Oral Diseases Mar 2020Growing evidence indicates that oral health and brain health are interconnected. Declining cognition and dementia coincide with lack of self-preservation, including oral... (Review)
Review
Growing evidence indicates that oral health and brain health are interconnected. Declining cognition and dementia coincide with lack of self-preservation, including oral hygiene. The oral microbiota plays an important role in maintaining oral health. Emerging evidence suggests a link between oral dysbiosis and cognitive decline in patients with Alzheimer's disease. This review showcases the recent advances connecting oral health and cognitive function during aging and the potential utility of oral-derived biospecimens to inform on brain health. Collectively, experimental findings indicate that the connection between oral health and cognition cannot be underestimated; moreover, oral biospecimens are abundant and readily obtainable without invasive procedures, which may help inform on cognitive health.
Topics: Alzheimer Disease; Cognition; Cognitive Dysfunction; Dementia; Disease Progression; Humans; Microbiota; Mouth; Oral Health
PubMed: 31541581
DOI: 10.1111/odi.13201 -
Health Promotion Practice Sep 2017In a personalized medicine environment, it is necessary to have access to a range of biospecimens to establish optimal plans for disease diagnosis and treatment for...
In a personalized medicine environment, it is necessary to have access to a range of biospecimens to establish optimal plans for disease diagnosis and treatment for individual patients. Cancer research is especially dependent on biospecimens for determining ideal personalized treatment for patients. Unfortunately, the vast majority of biospecimens are collected from non-Hispanic White individuals; thus, minority representation is lacking. This has negative implications for comprehensive cancer treatment. The Geographic Management of Cancer Health Disparities Program (GMaP) Region 6 implemented a series of biospecimen education seminars adapted from the Biospecimen and Biobanking module of an existing Cancer Education and Training Program. Regional GMaP partners participated in a train-the-trainer webinar to familiarize themselves with the training materials. Participants trained by the trainers completed pre- and posttests to document changes in awareness, knowledge, and intention. Nine biospecimen education seminars were offered in 2013; 255 health care professionals and representatives from community organizations attended. Participants demonstrated a significant increase in knowledge, intention to donate samples, and intention to talk to patients about biospecimen sample donation. Representatives from community organizations had more improvement on knowledge scores than health care providers. Participation in a well-designed biospecimen education program may ameliorate some of the distrust of biomedical research experienced by racial/ethnic minorities and, in turn, increase needed minority representation in biospecimen collection.
Topics: Adolescent; Adult; Ethnicity; Female; Health Education; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Neoplasms; Specimen Handling; Young Adult
PubMed: 27118784
DOI: 10.1177/1524839916641069 -
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 -
Genome Medicine Nov 2023Biorepositories archive and distribute well-characterized biospecimens for research to support the development of medical diagnostics and therapeutics. Knowledge of...
BACKGROUND
Biorepositories archive and distribute well-characterized biospecimens for research to support the development of medical diagnostics and therapeutics. Knowledge of biobanking and associated practices is incomplete in low- and middle-income countries where disease burden is disproportionately high. In 2011, the African Society of Human Genetics (AfSHG), the National Institutes of Health (NIH), and the Wellcome Trust founded the Human Heredity and Health in Africa (H3Africa) consortium to promote genomic research in Africa and established a network of three biorepositories regionally located in East, West, and Southern Africa to support biomedical research. This manuscript describes the processes established by H3Africa biorepositories to prepare research sites to collect high-quality biospecimens for deposit at H3Africa biorepositories.
METHODS
The biorepositories harmonized practices between the biorepositories and the research sites. The biorepositories developed guidelines to establish best practices and define biospecimen requirements; standard operating procedures (SOPs) for common processes such as biospecimen collection, processing, storage, transportation, and documentation as references; requirements for minimal associated datasets and formats; and a template material transfer agreements (MTA) to govern biospecimen exchange. The biorepositories also trained and mentored collection sites in relevant biobanking processes and procedures and verified biospecimen deposit processes. Throughout these procedures, the biorepositories followed ethical and legal requirements.
RESULTS
The 20 research projects deposited 107,982 biospecimens (76% DNA, 81,067), in accordance with the ethical and legal requirements and established best practices. The biorepositories developed and customized resources and human capacity building to support the projects. [The biorepositories developed 34 guidelines, SOPs, and documents; trained 176 clinicians and scientists in over 30 topics; sensitized ethical bodies; established MTAs and reviewed consent forms for all projects; attained import permits; and evaluated pilot exercises and provided feedback.
CONCLUSIONS
Biobanking in low- and middle-income countries by local skilled staff is critical to advance biobanking and genomic research and requires human capacity and resources for global partnerships. Biorepositories can help build human capacity and resources to support biobanking by partnering with researchers. Partnerships can be structured and customized to incorporate document development, ethics, training, mentorship, and pilots to prepare sites to collect, process, store, and transport biospecimens of high quality for future research.
Topics: Humans; Biological Specimen Banks; Africa; Biomedical Research; Genomics; Genome
PubMed: 37932809
DOI: 10.1186/s13073-023-01235-x