It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies
Immunotherapy for cancer is now a standard pillar in the armamentarium of treatments for many cancers. Immune checkpoint inhibitors, in particular, have resulted in significant therapeutic benefit and prolongation of survival in solid organ cancers, such as melanoma and lung cancer. However, the ext...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2021-07-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/9/7/e003212.full |
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| author | Michael D Green Lili Zhao Dean E Brenner Cindy Y Jiang Zeqi Niu Shelby Raupp Brittany Pannecouk Sunitha Nagrath Nithya Ramnath |
| author_facet | Michael D Green Lili Zhao Dean E Brenner Cindy Y Jiang Zeqi Niu Shelby Raupp Brittany Pannecouk Sunitha Nagrath Nithya Ramnath |
| author_sort | Michael D Green |
| collection | DOAJ |
| description | Immunotherapy for cancer is now a standard pillar in the armamentarium of treatments for many cancers. Immune checkpoint inhibitors, in particular, have resulted in significant therapeutic benefit and prolongation of survival in solid organ cancers, such as melanoma and lung cancer. However, the extent of benefit is not uniform. There are several groups studying predictors of benefit from these therapies. Recently, there has been a burgeoning interest in studying predictive biomarkers from the blood. These markers include circulating tumor DNA, circulating tumor cells, lymphocyte subpopulations, exosomes and metabolites to name a few. The logistics involved in such biomarker work are complex and rigorous with potential to impact a given study. Such pre-analytic components include development of a rigorous protocol, standard operating procedures for collection and storage of various blood components, ethics of patient consent, personnel involved as well as budget considerations. In this primer, we lay out representative aspects of each of the aforementioned components as a guide to blood-based biomarker research for immunotherapy studies in cancer. |
| format | Article |
| id | doaj-art-a3e7592b2b7b405d94fe4e9945cc66b2 |
| institution | DOAJ |
| issn | 2051-1426 |
| language | English |
| publishDate | 2021-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-a3e7592b2b7b405d94fe4e9945cc66b22025-08-20T02:49:53ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262021-07-019710.1136/jitc-2021-003212It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studiesMichael D Green0Lili Zhao1Dean E Brenner2Cindy Y Jiang3Zeqi Niu4Shelby Raupp5Brittany Pannecouk6Sunitha Nagrath7Nithya Ramnath8chemistNeurology, Xi`an Jiaotong University Second Affiliated Hospital, Xi`an, Shaanxi, China6 Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA1 Internal Medicine, University of Michigan, Michigan Medicine, Ann Arbor, Michigan, USA2 Department of Chemical Engineering, University of Michigan, Ann Arbor, Michigan, USA5 Precision Oncology Program, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, USA5 Precision Oncology Program, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, USA2 Department of Chemical Engineering, University of Michigan, Ann Arbor, Michigan, USA5 Precision Oncology Program, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, USAImmunotherapy for cancer is now a standard pillar in the armamentarium of treatments for many cancers. Immune checkpoint inhibitors, in particular, have resulted in significant therapeutic benefit and prolongation of survival in solid organ cancers, such as melanoma and lung cancer. However, the extent of benefit is not uniform. There are several groups studying predictors of benefit from these therapies. Recently, there has been a burgeoning interest in studying predictive biomarkers from the blood. These markers include circulating tumor DNA, circulating tumor cells, lymphocyte subpopulations, exosomes and metabolites to name a few. The logistics involved in such biomarker work are complex and rigorous with potential to impact a given study. Such pre-analytic components include development of a rigorous protocol, standard operating procedures for collection and storage of various blood components, ethics of patient consent, personnel involved as well as budget considerations. In this primer, we lay out representative aspects of each of the aforementioned components as a guide to blood-based biomarker research for immunotherapy studies in cancer.https://jitc.bmj.com/content/9/7/e003212.full |
| spellingShingle | Michael D Green Lili Zhao Dean E Brenner Cindy Y Jiang Zeqi Niu Shelby Raupp Brittany Pannecouk Sunitha Nagrath Nithya Ramnath It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies Journal for ImmunoTherapy of Cancer |
| title | It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies |
| title_full | It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies |
| title_fullStr | It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies |
| title_full_unstemmed | It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies |
| title_short | It’s not ‘just a tube of blood’: principles of protocol development, sample collection, staffing and budget considerations for blood-based biomarkers in immunotherapy studies |
| title_sort | it s not just a tube of blood principles of protocol development sample collection staffing and budget considerations for blood based biomarkers in immunotherapy studies |
| url | https://jitc.bmj.com/content/9/7/e003212.full |
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