Biomarkers for Diagnosis of Lung Cancer

Lung Cancer Clinical Trial

Official title:

Biomarkers for Diagnosis of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050100
• Other study ID #: SKTCTCH0001
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: May 11, 2017
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2017
• Source: SK Medical (Beijing) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms

Locations

Country	Name	City	State
China	The Second Affliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Zhongshan Hospital Fudan University	Shang Hai
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Henan province People's hospital	Zheng zhou

Sponsors (1)

Lead Sponsor	Collaborator
SK Medical (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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