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

NCT02907606 | Unknown

• 1 other identifier: PKUPH-XW1401
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Non-small-cell Lung Cancer; Lung Neoplasms

Keywords

Non-small-cell Lung Cancer; circulating tumor DNA; urine

Outcome Measures

Primary Outcomes (1)

• The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.

  12 months

Secondary Outcomes (4)

• The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.

  18 months

• Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.

  18 months

• Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.

  3 years

• Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• San Valley Biotechnology Incorporated: collaborator

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, +86-010, China

Location

Related Publications (6)

• 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.

  PMID: 27468937 BACKGROUND

• 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.

  PMID: 18837947 BACKGROUND

• 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.

  PMID: 21726666 BACKGROUND

• 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.

  PMID: 25003820 BACKGROUND

• 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.

  PMID: 25324352 BACKGROUND

• 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.

  PMID: 23836314 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumor tissue, peripheral blood samples and urinary samples will be collected from each patient. Time:Preoperative, intraoperative, 3 days and 1、6、12 months after surgery.

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiao Li, M.D

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiao Li, M.D

CONTACT

86-10-88326652; dr.lixiao@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Department

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2020
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)