Early Cancer Detection Test - Lung Cancer China (ECLC)

Bai Chunxue

Status: Unknown

Conditions: Lung Cancer

Treatments: Diagnostic Test: Tumor autoantibody detection

Study type: Observational

Funder types: Other

Identifiers

NCT04216511

CAALC-007-EarlyCDT Lung China

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Case-Lung Cancer

Description:

Patients with definite lung cancer diagnosis

Treatment:

Diagnostic Test: Tumor autoantibody detection

Control

Description:

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

Treatment:

Diagnostic Test: Tumor autoantibody detection