Biomarkers for Diagnosis of Lung Cancer
Conditions
Lung Cancer - Lung Neoplasm
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
primary lung adenocarcinoma Stages I, II, IIIA, IIIB, squamous cell carcinoma Stages I, II, IIIA, IIIB, benign non-calcified pulmonary nodules, early detection
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Status: Recruiting
Contact: Muyun Zhu, M.D. - (86) 13852781117 - yzszmy@163.com
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Status: Recruiting
Contact: Zuke Xiao, MD - xiaozuke@126.com
The Second Affliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Kai Wang, MD - doctorhuxi@163.com
Zhongshan Hospital Fudan University
Shang Hai, China
Status: Recruiting
Contact: Chunxue Bai - (86) 13681971807 - bai.chunxue@zs-hospital.sh.cn
Henan province People's hospital
Zheng zhou, China
Status: Recruiting
Contact: Xiaoju Zhang - (86) 15837101166 - zhangxiaoju1010@hotmail.com
Start Date
January 2014
Completion Date
February 2015
Sponsors
SK Medical (Beijing) Co., Ltd.
Source
SK Medical (Beijing) Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page