Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2014-01-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lung Cancer
Early-late stage primary lung cancer
No interventions assigned to this group
Lung Neoplasm
Benign non-calcified pulmonary nodules
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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SK Medical (Beijing) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chunxue Bai, M.D, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital Fudan Universit
Xiaoju Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Muyun Zhu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northern Jiangsu People's Hospital
Kai Wang, MD
Role: PRINCIPAL_INVESTIGATOR
The Second Affliated Hospital of Zhejiang University School of Medicine
Zuke Xiao, MD
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Provincial People's Hopital
Locations
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Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The Second Affliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhongshan Hospital Fudan University
Shanghai, , China
Henan province People's hospital
Zhengzhou, , China
Countries
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Other Identifiers
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SKTCTCH0001
Identifier Type: -
Identifier Source: org_study_id
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