Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
NCT ID: NCT03578185
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
800 participants
OBSERVATIONAL
2018-04-11
2025-12-31
Brief Summary
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Detailed Description
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* Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance.
* The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator \[Clinical data acquisition\]
* Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)
* Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites
* Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed lung cancer patients
3. Patient treated with immune checkpoint inhibitor
Exculsion Criteria:
NA
18 Years
ALL
No
Sponsors
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Se-Hoon Lee
OTHER
Responsible Party
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Se-Hoon Lee
Professor
Principal Investigators
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Se-hoon Lee, MD
Role: STUDY_CHAIR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Seoul National University Hospital
Seoul, Joungro-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.
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.
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.
Other Identifiers
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Lung cancer Biomarker_2018
Identifier Type: -
Identifier Source: org_study_id