Clinical trial NCT01928836: Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Keywords: Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Biological Markers
ROC Curve
Delayed Diagnosis
Lead sponsor: Chinese Alliance Against Lung Cancer
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Peking Union Medical College Hospital
name: Nanjing PLA General Hospital
name: Third Military Medical University
name: First Affiliated Hospital of Zhejiang University
name: Henan Provincial People's Hospital
First posted: 2013-08-27
Enrollment: 764
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence rate of lung cancer
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chongqing
country: China
facility: Third Military Medical University
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
city: Nanjing
country: China
facility: Nanjing PLA General Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Zhengzhou
country: China
facility: Henan Provincial Hospital
Study officials:
affiliation: Chinese Alliance Against Lung Cancer
name: Chunxue Bai, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang D, Zhang X, Powell CA, Ni J, Wang B, Zhang J, Zhang Y, Wang L, Xu Z, Zhang L, Wu G, Song Y, Tian W, Hu JA, Zhang Y, Hu J, Hong Q, Song Y, Zhou J, Bai C. Probability of cancer in high-risk patients predicted by the protein-based lung cancer biomarker panel in China: LCBP study. Cancer. 2018 Jan 15;124(2):262-270. doi: 10.1002/cncr.31020. Epub 2017 Sep 20.
citation: Yang D, Zhou J, Zeng T, Yang Z, Wang X, Hu J, Song Y, Chen L, Peer D, Wang X, Bai C. Serum chemokine network correlates with chemotherapy in non-small cell lung cancer. Cancer Lett. 2015 Aug 28;365(1):57-67. doi: 10.1016/j.canlet.2015.05.001. Epub 2015 May 11.