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This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.
[Sample acquisition]
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| Measure | Description | Time Frame |
|---|---|---|
| List of biomarkers | Neoantigen, tumor mutation burden, MHC compatibility, T-cell receptor and associated immune gene signature (IFN-r, interferons such as IL-2 and interleukin family), T-cell subset (T cell surface marker such as CD4+, CD7+, CD8+, CD16, CD34+, CD38+, CD56+, etc.), PD-1/PD-L1 expression, etc. | Baseline |
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Inclusion Criteria:
Exculsion Criteria:
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Total of 800 lung cancer patients treated with immune checkpoint inhibitor Study will be initiated from the date of IRB approval to Dec. 2020 for those who signed for master agreement for tissue donation for research purposes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Se-hoon Lee, MD | Contact | +82-10-4759-7640 | sehoon.lee@samsung.com | |
| Jinhee Seo | Contact | +82-70-7014-4158 | rufina.seo@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Se-hoon Lee, MD | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-gu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22042955 | Background | Topalian SL, Weiner GJ, Pardoll DM. Cancer immunotherapy comes of age. J Clin Oncol. 2011 Dec 20;29(36):4828-36. doi: 10.1200/JCO.2011.38.0899. Epub 2011 Oct 31. | |
| 22658128 | Background | Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The following analysis will be conducted using samples (tissue, blood, fecal material) form the patient who treated with immune checkpoint inhibitor
| Seoul National University Hospital | Recruiting | Seoul | Joungro-gu | South Korea |
|
| Asan Medical Center | Not yet recruiting | Seoul | Songpa-gu | South Korea |
|
| 22437870 | Background | Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239. |
| 20516446 | Background | Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, Stankevich E, Pons A, Salay TM, McMiller TL, Gilson MM, Wang C, Selby M, Taube JM, Anders R, Chen L, Korman AJ, Pardoll DM, Lowy I, Topalian SL. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010 Jul 1;28(19):3167-75. doi: 10.1200/JCO.2009.26.7609. Epub 2010 Jun 1. |
| 25977344 | Background | Patnaik A, Kang SP, Rasco D, Papadopoulos KP, Elassaiss-Schaap J, Beeram M, Drengler R, Chen C, Smith L, Espino G, Gergich K, Delgado L, Daud A, Lindia JA, Li XN, Pierce RH, Yearley JH, Wu D, Laterza O, Lehnert M, Iannone R, Tolcher AW. Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. Clin Cancer Res. 2015 Oct 1;21(19):4286-93. doi: 10.1158/1078-0432.CCR-14-2607. Epub 2015 May 14. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |