NCT02050100CompletedNot Applicable
Biomarkers for Diagnosis of Lung Cancer
SK Medical (Beijing) Co., Ltd.5 sites in 1 country300 target enrollmentStarted: January 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Identification of blood biomarkers for detection of lung cancer
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Identification of blood biomarkers for detection of lung cancer
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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