Clinical trial NCT02907606: Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
Official title: Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Non-small-cell Lung Cancer
Lung Neoplasms
Keywords: Non-small-cell Lung Cancer
circulating tumor DNA
urine
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: San Valley Biotechnology Incorporated
First posted: 2016-09-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed stage non-small cell lung cancer patients with paired tumor tissue, peripheral blood samples, and urinary samples.

Brief summary: 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.

Detailed description: Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.
timeFrame: 12 months
Secondary outcomes:
measure: The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.
timeFrame: 18 months
measure: Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.
timeFrame: 18 months
measure: Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.
timeFrame: 3 years
measure: Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People'S Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiao Li, M.D
role: STUDY_DIRECTOR
References:
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 Oct;11(10):1690-700. doi: 10.1016/j.jtho.2016.05.035. Epub 2016 Jul 25.
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.
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.
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. doi: 10.18632/oncotarget.1964.
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.
citation: 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.