Early Cancer Detection Test - Lung Cancer China

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Tumor autoantibody detection

• Registration Number: NCT04216511
• Lead Sponsor: Bai Chunxue

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 available

Study Timeline

• Study Start: 2019-08-22
• Status Verified: 2019-12
• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2019-12-31
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Primary Completion: 2020-10
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case-Lung Cancer	Tumor autoantibody detection	Patients with definite lung cancer diagnosis
Control	Tumor autoantibody detection	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

Primary Outcome Measures

Name	Time	Method
Autoantibody panel with best clinical performance in Chinese population	Oct.30, 2020	The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.

Trial Locations

Locations (3)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China

Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Henan Province People's Hospital; 🇨🇳 Zhengzhou, China