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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

Tracking Information
First Submitted Date December 31, 2019
First Posted Date January 2, 2020
Last Update Posted Date January 2, 2020
Actual Study Start Date August 22, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 31, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Cancer Detection Test - Lung Cancer China
Official Title Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum or plasma
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.
Condition Lung Cancer
Intervention Diagnostic Test: Tumor autoantibody detection
Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.
Study Groups/Cohorts
  • Case-Lung Cancer
    Patients with definite lung cancer diagnosis
    Intervention: Diagnostic Test: Tumor autoantibody detection
  • 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
    Intervention: Diagnostic Test: Tumor autoantibody detection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 31, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chunxue Bai, MD 18621170011 bai.chunxue@zs-hospital.sh.cn
Contact: Jian Zhou, MD 18221223320 zhou.jian@fudan.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04216511
Other Study ID Numbers CAALC-007-EarlyCDT Lung China
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bai Chunxue, Chinese Alliance Against Lung Cancer
Study Sponsor Bai Chunxue
Collaborators Gene Tech (Shanghai) Company Limited
Investigators
Principal Investigator: Chunxue Bai, MD Fudan University
PRS Account Chinese Alliance Against Lung Cancer
Verification Date December 2019