Lung NeoplasmsLCBPNCT01928836
Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China
An observational study of Lung Neoplasms, run by Bai Chunxue at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Lung Neoplasms
- How many people
- 764 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2012to Jan 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Non-suspected lung cancer group (600 cases)
- Aged 40 to 75 years;
- Male smoker (≥400 cig/year), female smoker or non-smoker;
- Visible lung nodule lesion in the chest (based on local CT result);
- Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
- Suspected lung cancer group (600 cases)
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- Aged 40 to 75 years;
- Male smoker (≥400 cig/year), female smoker or non-smoker;
- Visible lung cancer lesion in the chest (based on local CT result);
- With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
Who cannot join
- Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
- Already treated by chemotherapy or surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking Union Medical College Hospital
Beijing, 100730
Third Military Medical University
Chongqing, 400037
First Affiliated Hospital of Zhejiang University
Hangzhou, 310003
Nanjing PLA General Hospital
Nanjing, 210002
Shanghai Zhongshan Hospital
Shanghai, 200032
Henan Provincial Hospital
Zhengzhou, 450000
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasms
- Keywords
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Biological Markers, ROC Curve, Delayed Diagnosis
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of lung cancer
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 764 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bai Chunxue
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Bai Chunxue, Chinese Alliance Against Lung Cancer
- Investigators
- Chunxue Bai, Prof., Principal investigator, Chinese Alliance Against Lung Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928836
- Sponsor's protocol ID
- CAALC-001-LCBP
- Acronym
- LCBP
- Status last verified
- May 2015
- First submitted
- 20 Aug 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28940455Yang 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.
PubMed 25976768
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01928836
- Acronym / sponsor ID
- LCBP / CAALC-001-LCBP
- Conditions
- Lung Neoplasms
- Keywords
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Biological Markers, ROC Curve, Delayed Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Bai ChunxueUniversity, hospital or other
- 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
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Non-suspected lung cancer group (600 cases)
- Suspected lung cancer group (600 cases)
Key exclusion criteria (2 listed)
- Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
- Already treated by chemotherapy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate of lung cancer
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 28940455Yang 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.
- Derived from this study: PubMed 25976768Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunxue Bai, Prof. principal investigator
Chinese Alliance Against Lung Cancer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Bai Chunxue at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of lung cancer (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928836, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.