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Early Cancer Detection Test - Lung Cancer China (ECLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216511
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Gene Tech (Shanghai) Company Limited
Information provided by (Responsible Party):
Bai Chunxue, Chinese Alliance Against Lung Cancer

Brief Summary:
Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.

Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: Tumor autoantibody detection

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case-Lung Cancer
Patients with definite lung cancer diagnosis
Diagnostic Test: Tumor autoantibody detection
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.

Control
Either patients with benign pulmonary nodule, or healthy individuals without pulmonary nodule but with risk factors to develop lung cancer matched to lung cancer group
Diagnostic Test: Tumor autoantibody detection
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.




Primary Outcome Measures :
  1. Autoantibody panel with best clinical performance in Chinese population [ Time Frame: Oct.30, 2020 ]
    The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.


Biospecimen Retention:   Samples Without DNA
serum or plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.
Criteria

Inclusion Criteria:

  • Male or female aged 18 or above.
  • Individuals complying with either of the following

    1. diagnosed as lung cancer (histopathologically confirmed);
    2. diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
    3. without pulmonary nodule but with lung cancer risk factor, age & gender matched recruited lung cancer patients.
  • Participant is willing and able to provide necessary information required in CRF.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • History of any cancer;
  • Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216511


Contacts
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Contact: Chunxue Bai, MD 18621170011 bai.chunxue@zs-hospital.sh.cn
Contact: Jian Zhou, MD 18221223320 zhou.jian@fudan.edu.cn

Locations
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China, Shanghai
Zhongshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Chunxue Bai, MD    18621170011    bai.chunxue@zs-hospital.sh.cn   
Contact: Jian Zhou, MD    18221223320    zhou.jian@fudan.edu.cn   
China
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Jiayuan Sun, MD    86-21-22200000 ext 1511    jysun1976@163.com   
Henan Province People's Hospital Not yet recruiting
Zhengzhou, China
Contact: Xiaoju Zhang       zhangxiaoju1010@hotmail.com   
Sponsors and Collaborators
Bai Chunxue
Gene Tech (Shanghai) Company Limited
Investigators
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Principal Investigator: Chunxue Bai, MD Fudan University
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Responsible Party: Bai Chunxue, Chairman, Chinese Alliance Against Lung Cancer
ClinicalTrials.gov Identifier: NCT04216511    
Other Study ID Numbers: CAALC-007-EarlyCDT Lung China
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bai Chunxue, Chinese Alliance Against Lung Cancer:
Tumor Autoantibody
Early Detection
Indeterminate Pulmonary Nodule
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs