Biomarkers for Diagnosis of Lung Cancer

Sponsor

SK Medical (Beijing) Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02050100

Collaborator

(none)

300

Enrollment

Locations

15.9

Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Neoplasm

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biomarkers for Diagnosis of Lung Cancer

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Lung Cancer Early-late stage primary lung cancer
Lung Neoplasm Benign non-calcified pulmonary nodules

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001
2	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi	China
3	The Second Affliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
4	Zhongshan Hospital Fudan University	Shang Hai		China
5	Henan province People's hospital	Zheng zhou		China

Sponsors and Collaborators

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 Province 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