Biomarkers for Diagnosis of Lung Cancer

Completed

• Conditions: Lung Cancer; Lung Neoplasm

• Registration Number: NCT02050100
• Lead Sponsor: SK Medical (Beijing) Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of blood biomarkers for detection of lung cancer	6 months after enrollment	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.

Trial Locations

Locations (5)

Jiangxi Provincial People's Hospital; 🇨🇳 Nanchang, Jiangxi, China

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China

Henan province People's hospital; 🇨🇳 Zheng zhou, China

The Second Affliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Zhongshan Hospital Fudan University; 🇨🇳 Shang Hai, China