Lung Neoplasms Clinical Trial
Official title:
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | August 2020 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Aged 18 to 80 years - 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: - Unable to comply with the study procedure - Malignant tumor history within the past 5 years - Coexisting small cell lung cancer - Unqualified tissue, blood or urine samples |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Peking University People'S Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | San Valley Biotechnology Incorporated |
China,
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Jul 25. pii: S1556-0864(16)30587-1. doi: 10.1016/j.jtho.2016.05.035. [Epub ahead of print] — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA. | 12 months | Yes | |
Secondary | The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients. | 18 months | Yes | |
Secondary | Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis. | 18 months | Yes | |
Secondary | Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches. | 3 years | Yes | |
Secondary | Urinary ctDNA predictive value for locoregional recurrence and distant metastasis. | 3 years | Yes |
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