Biomarkers for Diagnosis of Lung Cancer

SK Medical

Status: Completed

Conditions: Lung Cancer; Lung Neoplasm

Study type: Observational

Funder types: Industry

Identifiers

NCT02050100

SKTCTCH0001

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

300 participants in 2 patient groups

Lung Cancer

Description:

Early-late stage primary lung cancer

Lung Neoplasm

Description:

Benign non-calcified pulmonary nodules