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

Completed

• Conditions: Lung Neoplasms

• Registration Number: NCT01928836
• Lead Sponsor: Bai Chunxue

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.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-24
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of lung cancer	Up to 1 year

Trial Locations

Locations (6)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China

Nanjing PLA General Hospital; 🇨🇳 Nanjing, China

Third Military Medical University; 🇨🇳 Chongqing, China

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Henan Provincial Hospital; 🇨🇳 Zhengzhou, China