Early Cancer Detection Test - Lung Cancer China

Lung Cancer Clinical Trial

— ECLC  

Official title:

Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216511
• Other study ID #: CAALC-007-EarlyCDT Lung China
• Status: Recruiting
• Start date: August 22, 2019
• Est. completion date: June 2021

Study information

• Verified date: December 2019
• Source: Chinese Alliance Against Lung Cancer
• Contact: Chunxue Bai, MD
• Phone: 18621170011
• Email: bai.chunxue[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Henan Province People's Hospital	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Bai Chunxue	Gene Tech (Shanghai) Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoantibody panel with best clinical performance in Chinese population	The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.	Oct.30, 2020