Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

Lung Neoplasms Clinical Trial

Official title:

Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02907606
• Other study ID #: PKUPH-XW1401
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 14, 2016
• Start date: September 2016
• Est. completion date: August 2020

Study information

• Verified date: September 2016
• Source: Peking University People's Hospital
• Contact: Xiao Li, M.D
• Phone: 86-10-88326652
• Email: dr.lixiao[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
China	Peking University People'S Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	San Valley Biotechnology Incorporated

Country where clinical trial is conducted

China, 

References & Publications (6)

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

Outcome

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