Biomarkers for Diagnosis of Lung Cancer

NCT02050100 | Completed

• 1 other identifier: SKTCTCH0001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Cancer; Lung Neoplasm

Keywords

primary lung adenocarcinoma Stages I, II, IIIA, IIIB; squamous cell carcinoma Stages I, II, IIIA, IIIB; benign non-calcified pulmonary nodules; early detection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lung Cancer

Early-late stage primary lung cancer

Lung Neoplasm

Benign non-calcified pulmonary nodules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Medical (Beijing) Co., Ltd.: lead

Study Sites (5)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

The Second Affliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

Henan province People's hospital

Zhengzhou, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Two 10ml blood samples (serum and plasma) from the patient will be analyzed for protein biomarkers associated with lung cancer diagnosis

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

CN (5)