Literature DB >> 29218266

Ensuring sample quality for blood biomarker studies in clinical trials: a multicenter international study for plasma and serum sample preparation.

Feng-Ming Spring Kong1, Lujun Zhao2, Luhua Wang3, Yuhchyau Chen4, Jie Hu5, Xiaolong Fu6, Chunxue Bai5, Li Wang7, Theodore S Lawrence8, Mitchell S Anscher7, Adam Dicker9, Paul Okunieff10.   

Abstract

BACKGROUND: Sample quality is critical for biomarker detection in oncology, and platelet degradation and contamination in plasma have a remarkable impact on the ability to accurately quantify many blood-based biomarkers. Platelet factor 4 (PF4) can be used as an indicator to monitor sample quality. This multicenter study aimed to determine the impact of critical components of the blood sample handling process on platelet degradation/contamination and to establish an optimal method for collecting platelet-poor plasma samples.
METHODS: At each of six participating centers, blood samples were drawn from 12-13 healthy volunteers. Serum and plasma samples were prepared from whole blood samples using nine different methods that have been commonly used in ongoing multicenter trials. PF4 levels in the prepared samples were measured by enzyme-linked immunosorbent assay (ELISA). Paired t-tests were used for statistical analysis.
RESULTS: Blood samples were collected from 74 subjects enrolled in six centers. PF4 levels were significantly higher in serum samples than in plasma samples (P<0.001), in plasma samples from blood that sat at room temperature for 5 minutes (P=0.021), in plasma samples prepared at an insufficient centrifugal force (P<0.001), and in plasma samples prepared from blood that sat for longer than 4 hours on ice (P=0.001). For each method, the PF4 levels did not differ significantly among the centers or between Chinese and American subjects. The methods that resulted in normal levels of PF4 involved keeping blood samples on ice for 30 minutes to <4 hours and centrifugation at 2,500-3,000 ×g for 30 min.
CONCLUSIONS: This multicenter study evaluated multiple blood sample handling conditions for minimizing platelet degradation during plasma serum preparation and determined an optimal method for preparing platelet-poor plasma. The findings of this study can be applied in future blood biomarker studies.

Entities:  

Keywords:  Plasma; biomarker study; platelet factor 4 (PF4); serum

Year:  2017        PMID: 29218266      PMCID: PMC5709139          DOI: 10.21037/tlcr.2017.09.13

Source DB:  PubMed          Journal:  Transl Lung Cancer Res        ISSN: 2218-6751


  29 in total

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2.  In regard to De Jaeger et al.: significance of plasma transforming growth factor-beta levels in radiotherapy for non-small-cell lung cancer (INT J RADIAT ONCOL BIOL PHYS 2004;58:1378-1387).

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4.  Predicting the risk of symptomatic radiation-induced lung injury using both the physical and biologic parameters V(30) and transforming growth factor beta.

Authors:  X L Fu; H Huang; G Bentel; R Clough; R L Jirtle; F M Kong; L B Marks; M S Anscher
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5.  Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

Authors:  Melissa K Tuck; Daniel W Chan; David Chia; Andrew K Godwin; William E Grizzle; Karl E Krueger; William Rom; Martin Sanda; Lynn Sorbara; Sanford Stass; Wendy Wang; Dean E Brenner
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6.  Transforming growth factor-beta plasma dynamics and post-irradiation lung injury in lung cancer patients.

Authors:  Alena Novakova-Jiresova; Mieke M Van Gameren; Rob P Coppes; Harm H Kampinga; Harry J M Groen
Journal:  Radiother Oncol       Date:  2004-05       Impact factor: 6.280

7.  Histopathologic amelioration of fibroproliferative change in rat irradiated lung using soluble transforming growth factor-beta (TGF-beta) receptor mediated by adenoviral vector.

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8.  Transforming growth factor-beta1 circulates in normal human plasma and is unchanged in advanced metastatic breast cancer.

Authors:  L M Wakefield; J J Letterio; T Chen; D Danielpour; R S Allison; L H Pai; A M Denicoff; M H Noone; K H Cowan; J A O'Shaughnessy
Journal:  Clin Cancer Res       Date:  1995-01       Impact factor: 12.531

9.  Soluble TGFbeta type II receptor gene therapy ameliorates acute radiation-induced pulmonary injury in rats.

Authors:  Zahid N Rabbani; Mitchell S Anscher; Xiuwu Zhang; Liguang Chen; Thaddeus V Samulski; Chuan-Yuan Li; Zeljko Vujaskovic
Journal:  Int J Radiat Oncol Biol Phys       Date:  2003-10-01       Impact factor: 7.038

10.  Proteomic strategies and their application in cancer research.

Authors:  Riccardo Alessandro; Simona Fontana; Elise Kohn; Giacomo De Leo
Journal:  Tumori       Date:  2005 Nov-Dec
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