NCT01928836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
764

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

August 20, 2013

Last Update Submit

May 24, 2015

Conditions

Lung Neoplasms

Keywords

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaBiological MarkersROC CurveDelayed Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of lung cancer

    Up to 1 year

Study Arms (2)

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.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
  • Already treated by chemotherapy or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Third Military Medical University

Chongqing, 400037, China

Location

First Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Nanjing PLA General Hospital

Nanjing, 210002, China

Location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

Henan Provincial Hospital

Zhengzhou, 450000, China

Location

Related Publications (2)

  • 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.

    PMID: 28940455DERIVED

  • 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.

    PMID: 25976768DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

10mL blood sample of the patient will be tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Chunxue Bai, Prof.

    Chinese Alliance Against Lung Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 27, 2013

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

CN(6)