Biomarkers for Diagnosis of Lung Cancer

The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Lung Neoplasm

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Shang Hai, China
    • Zhongshan Hospital Fudan University
  • Zheng zhou, China
    • Henan Province People's Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 300 patients will be recruited from hospital pulmonary clinics. The study participants will have pulmonary nodules suspicious for lung cancer and a bronchial biopsy diagnosis of NSCLC or probable benign. Approximately half of the patients will be cases and half controls.

Description

Inclusion Criteria:

• Adults ≥ 18 years of age
• Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
• Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
• Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
• Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
• A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
• Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
• A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
• No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
• Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

Exclusion Criteria:

• Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
• Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
• Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lung Cancer; Early-late stage primary lung cancer
Lung Neoplasm; Benign non-calcified pulmonary nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of blood biomarkers for detection of lung cancer	SK Telecom will utilize 15 single-plex quantitative Polymerase Chain Reaction (qPCR) assays to analyze an initial set of 300 clinical samples in China. SomaLogic will analyze these samples on the SOMAscan array (>1000 proteins) for additional lung cancer biomarker candidates.	6 months after enrollment

Collaborators and Investigators

• Sponsor: SK Medical (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Chunxue Bai, M.D, Ph.D., Zhongshan Hospital Fudan Universit; Principal Investigator: Xiaoju Zhang, M.D., Henan Provincial People's Hospital; Principal Investigator: Muyun Zhu, M.D., Northern Jiangsu Province People's Hospital; Principal Investigator: Kai Wang, MD, The Second Affliated Hospital of Zhejiang University School of Medicine; Principal Investigator: Zuke Xiao, MD, Jiangxi Provincial People's Hopital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 28, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: early detection; primary lung adenocarcinoma Stages I, II, IIIA, IIIB; squamous cell carcinoma Stages I, II, IIIA, IIIB; benign non-calcified pulmonary nodules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SKTCTCH0001