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 inJournal of proteome research Vol. 8; no. 1; pp. 113 - 117
Main Authors Tuck, Melissa K, Chan, Daniel W, Chia, David, Godwin, Andrew K, Grizzle, William E, Krueger, Karl E, Rom, William, Sanda, Martin, Sorbara, Lynn, Stass, Sanford, Wang, Wendy, Brenner, Dean E
Format Journal Article
LanguageEnglish
Published United States American Chemical Society 01.01.2009
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Online AccessGet full text
ISSN1535-3893
1535-3907
DOI10.1021/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.
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
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  fullname: Chia, David
– sequence: 4
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  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
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– sequence: 10
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– 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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SubjectTerms Biomarkers - blood
Blood Preservation
Blood Proteins - analysis
Clinical Trials as Topic
Humans
Light
Practice Guidelines as Topic
Proteomics - methods
Proteomics - standards
Proteomics - trends
Reproducibility of Results
Specimen Handling - methods
Specimen Handling - trends
Temperature
Title Standard Operating Procedures for Serum and Plasma Collection: Early Detection Research Network Consensus Statement Standard Operating Procedure Integration Working Group
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