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Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China (LCBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928836
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
Peking Union Medical College Hospital
Nanjing PLA General Hospital
Third Military Medical University
First Affiliated Hospital of Zhejiang University
Henan Provincial People's Hospital
Information provided by (Responsible Party):
Bai Chunxue, Chinese Alliance Against Lung Cancer

Brief Summary:
The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

Condition or disease
Lung Neoplasms

Detailed Description:
The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 764 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multicenter Study for Risk Stratification of Patients Presenting With Symptoms Related to Lung Cancer Using the Lung Cancer Biomarker Panel (LCBP) in China
Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Non-suspected lung cancer group
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung nodule lesion in the chest (based on local CT result);
  4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
Suspected lung cancer group
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung cancer lesion in the chest (based on local CT result);
  4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.



Primary Outcome Measures :
  1. Incidence rate of lung cancer [ Time Frame: Up to 1 year ]

Biospecimen Retention:   Samples Without DNA
10mL blood sample of the patient will be tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group.
Criteria

Inclusion Criteria:

  • Non-suspected lung cancer group (600 cases)

    1. Aged 40 to 75 years;
    2. Male smoker (≥400 cig/year), female smoker or non-smoker;
    3. Visible lung nodule lesion in the chest (based on local CT result);
    4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  • Suspected lung cancer group (600 cases)

    1. Aged 40 to 75 years;
    2. Male smoker (≥400 cig/year), female smoker or non-smoker;
    3. Visible lung cancer lesion in the chest (based on local CT result);
    4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.

Exclusion Criteria:

  • Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
  • Already treated by chemotherapy or surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928836


Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
Third Military Medical University
Chongqing, China, 400037
First Affiliated Hospital of Zhejiang University
Hangzhou, China, 310003
Nanjing PLA General Hospital
Nanjing, China, 210002
Shanghai Zhongshan Hospital
Shanghai, China, 200032
Henan Provincial Hospital
Zhengzhou, China, 450000
Sponsors and Collaborators
Bai Chunxue
Shanghai Zhongshan Hospital
Peking Union Medical College Hospital
Nanjing PLA General Hospital
Third Military Medical University
First Affiliated Hospital of Zhejiang University
Henan Provincial People's Hospital
Investigators
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Principal Investigator: Chunxue Bai, Prof. Chinese Alliance Against Lung Cancer
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bai Chunxue, Director, Chinese Alliance Against Lung Cancer
ClinicalTrials.gov Identifier: NCT01928836    
Other Study ID Numbers: CAALC-001-LCBP
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Bai Chunxue, Chinese Alliance Against Lung Cancer:
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Biological Markers
ROC Curve
Delayed Diagnosis
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases