- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02050100
Biomarkers for Diagnosis of Lung Cancer
May 11, 2017 updated by: SK Medical (Beijing) Co., Ltd.
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shang Hai, China
- Zhongshan Hospital Fudan University
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Zheng zhou, China
- Henan province people's hospital
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Jiangsu
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Yangzhou, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital
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Jiangxi
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Nanchang, Jiangxi, China
- Jiangxi Provincial People's Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The Second Affliated Hospital of Zhejiang University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lung Cancer
Early-late stage primary lung cancer
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Lung Neoplasm
Benign non-calcified pulmonary nodules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of blood biomarkers for detection of lung cancer
Time Frame: 6 months after enrollment
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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.
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6 months after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chunxue Bai, M.D, Ph.D., Zhongshan Hospital Fudan Universit
- Principal Investigator: Xiaoju Zhang, M.D., Henan provincial people's hospital
- Principal Investigator: Muyun Zhu, M.D., Northern Jiangsu Province People's Hospital
- Principal Investigator: Kai Wang, MD, The Second Affliated Hospital of Zhejiang University School of Medicine
- Principal Investigator: Zuke Xiao, MD, Jiangxi Provincial People's Hopital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
January 20, 2014
First Submitted That Met QC Criteria
January 28, 2014
First Posted (Estimate)
January 30, 2014
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKTCTCH0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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