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

Lung Neoplasms Clinical Trial

— LCBP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928836
• Other study ID #: CAALC-001-LCBP
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: May 24, 2015
• Start date: October 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Chinese Alliance Against Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Third Military Medical University	Chongqing
China	First Affiliated Hospital of Zhejiang University	Hangzhou
China	Nanjing PLA General Hospital	Nanjing
China	Shanghai Zhongshan Hospital	Shanghai
China	Henan Provincial Hospital	Zhengzhou

Sponsors (7)

Lead Sponsor	Collaborator
Bai Chunxue	First Affiliated Hospital of Zhejiang University, Henan Provincial Hospital, Nanjing PLA General Hospital, Peking Union Medical College Hospital, Shanghai Zhongshan Hospital, Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of lung cancer		Up to 1 year	No