Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
NCT ID: NCT02907606
Last Updated: 2016-09-20
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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UNKNOWN
45 participants
OBSERVATIONAL
2016-09-30
2020-08-31
Brief Summary
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Detailed Description
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Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.
This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
* Completed and explicit information about TNM staging
* Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
* Patients must have given written informed consent
Exclusion Criteria
* Malignant tumor history within the past 5 years
* Coexisting small cell lung cancer
* Unqualified tissue, blood or urine samples
18 Years
80 Years
ALL
No
Sponsors
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San Valley Biotechnology Incorporated
UNKNOWN
Peking University People's Hospital
OTHER
Responsible Party
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Jun Wang
Chief of Thoracic Department
Principal Investigators
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Xiao Li, M.D
Role: STUDY_DIRECTOR
Peking University People's Hospital
Locations
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Peking University People'S Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Reckamp KL, Melnikova VO, Karlovich C, Sequist LV, Camidge DR, Wakelee H, Perol M, Oxnard GR, Kosco K, Croucher P, Samuelsz E, Vibat CR, Guerrero S, Geis J, Berz D, Mann E, Matheny S, Rolfe L, Raponi M, Erlander MG, Gadgeel S. A Highly Sensitive and Quantitative Test Platform for Detection of NSCLC EGFR Mutations in Urine and Plasma. J Thorac Oncol. 2016 Oct;11(10):1690-700. doi: 10.1016/j.jtho.2016.05.035. Epub 2016 Jul 25.
Su YH, Wang M, Brenner DE, Norton PA, Block TM. Detection of mutated K-ras DNA in urine, plasma, and serum of patients with colorectal carcinoma or adenomatous polyps. Ann N Y Acad Sci. 2008 Aug;1137:197-206. doi: 10.1196/annals.1448.027.
Lin SY, Dhillon V, Jain S, Chang TT, Hu CT, Lin YJ, Chen SH, Chang KC, Song W, Yu L, Block TM, Su YH. A locked nucleic acid clamp-mediated PCR assay for detection of a p53 codon 249 hotspot mutation in urine. J Mol Diagn. 2011 Sep;13(5):474-84. doi: 10.1016/j.jmoldx.2011.05.005. Epub 2011 Jul 2.
Janku F, Vibat CR, Kosco K, Holley VR, Cabrilo G, Meric-Bernstam F, Stepanek VM, Lin PP, Leppin L, Hassaine L, Poole JC, Kurzrock R, Erlander MG. BRAF V600E mutations in urine and plasma cell-free DNA from patients with Erdheim-Chester disease. Oncotarget. 2014 Jun 15;5(11):3607-10. doi: 10.18632/oncotarget.1964.
Hyman DM, Diamond EL, Vibat CR, Hassaine L, Poole JC, Patel M, Holley VR, Cabrilo G, Lu TT, Arcila ME, Chung YR, Rampal R, Lacouture ME, Rosen N, Meric-Bernstam F, Baselga J, Kurzrock R, Erlander MG, Janku F, Abdel-Wahab O. Prospective blinded study of BRAFV600E mutation detection in cell-free DNA of patients with systemic histiocytic disorders. Cancer Discov. 2015 Jan;5(1):64-71. doi: 10.1158/2159-8290.CD-14-0742. Epub 2014 Oct 16.
Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9.
Other Identifiers
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PKUPH-XW1401
Identifier Type: -
Identifier Source: org_study_id
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