Standard Operating Procedures for Serum and Plasma Collection: Early Detection Research Network Consensus Statement Standard Operating Procedure Integration Working Group
Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readi...
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Published in | Journal of proteome research Vol. 8; no. 1; pp. 113 - 117 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
American Chemical Society
01.01.2009
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Subjects | |
Online Access | Get full text |
ISSN | 1535-3893 1535-3907 |
DOI | 10.1021/pr800545q |
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Abstract | Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the “bench to bedside” aim of translational research. It is essential that standard operating procedures, “the how” of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation. |
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AbstractList | Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the “bench to bedside” aim of translational research. It is essential that standard operating procedures, “the how” of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation. Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation. |
Author | Tuck, Melissa K Rom, William Stass, Sanford Sanda, Martin Sorbara, Lynn Grizzle, William E Krueger, Karl E Godwin, Andrew K Wang, Wendy Chan, Daniel W Brenner, Dean E Chia, David |
AuthorAffiliation | Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland 21201-1192 Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan 48109-0725 Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 Department of Pathology, Johns Hopkins University, Baltimore, Maryland 21231 UCLA Immunogenetics Center, University of California, Los Angeles, California 90095-1652 Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111 Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 University of Alabama at Birmingham, Birmingham, Alabama 35233-0007 New York University School of Medicine, New York, New York 10016 |
AuthorAffiliation_xml | – name: Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 – name: Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland 21201-1192 – name: UCLA Immunogenetics Center, University of California, Los Angeles, California 90095-1652 – name: Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan 48109-0725 – name: Department of Pathology, Johns Hopkins University, Baltimore, Maryland 21231 – name: University of Alabama at Birmingham, Birmingham, Alabama 35233-0007 – name: Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892 – name: Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111 – name: New York University School of Medicine, New York, New York 10016 |
Author_xml | – sequence: 1 givenname: Melissa K surname: Tuck fullname: Tuck, Melissa K email: mtuck@umich.edu – sequence: 2 givenname: Daniel W surname: Chan fullname: Chan, Daniel W – sequence: 3 givenname: David surname: Chia fullname: Chia, David – sequence: 4 givenname: Andrew K surname: Godwin fullname: Godwin, Andrew K – sequence: 5 givenname: William E surname: Grizzle fullname: Grizzle, William E – sequence: 6 givenname: Karl E surname: Krueger fullname: Krueger, Karl E – sequence: 7 givenname: William surname: Rom fullname: Rom, William – sequence: 8 givenname: Martin surname: Sanda fullname: Sanda, Martin – sequence: 9 givenname: Lynn surname: Sorbara fullname: Sorbara, Lynn – sequence: 10 givenname: Sanford surname: Stass fullname: Stass, Sanford – sequence: 11 givenname: Wendy surname: Wang fullname: Wang, Wendy – sequence: 12 givenname: Dean E surname: Brenner fullname: Brenner, Dean E |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/19072545$$D View this record in MEDLINE/PubMed |
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