Clinical trial NCT02050100: Biomarkers for Diagnosis of Lung Cancer
Official title: Biomarkers for Diagnosis of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: SK Medical (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of blood biomarkers for detection of lung cancer
timeFrame: 6 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Hangzhou
country: China
facility: The Second Affliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Shang Hai
country: China
facility: Zhongshan Hospital Fudan University
city: Zheng zhou
country: China
facility: Henan province People's hospital
Study officials:
affiliation: Zhongshan Hospital Fudan Universit
name: Chunxue Bai, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Xiaoju Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Jiangsu People's Hospital
name: Muyun Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affliated Hospital of Zhejiang University School of Medicine
name: Kai Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangxi Provincial People's Hopital
name: Zuke Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References: