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

May 24, 2015 updated by: Bai Chunxue

Multicenter Study for Risk Stratification of Patients Presenting With Symptoms Related to Lung Cancer Using the Lung Cancer Biomarker Panel (LCBP) in China

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

764

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

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Chongqing, China, 400037
        • Third Military Medical University
      • Hangzhou, China, 310003
        • First affiliated Hospital of Zhejiang University
      • Nanjing, China, 210002
        • Nanjing PLA General Hospital
      • Shanghai, China, 200032
        • Shanghai Zhongshan Hospital
      • Zhengzhou, China, 450000
        • Henan Provincial Hospital

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of lung cancer
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bai Chunxue

Collaborators

Peking Union Medical College Hospital
Shanghai Zhongshan Hospital
First Affiliated Hospital of Zhejiang University
Third Military Medical University
Henan Provincial People's Hospital
Nanjing PLA General Hospital

Investigators

  • Principal Investigator: Chunxue Bai, Prof., Chinese Alliance Against Lung Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 24, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAALC-001-LCBP

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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