Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

Nucleix

Status

Active, not recruiting

Conditions

Lung Cancer

Treatments

Procedure: Blood collection

Study type

Observational

Funder types

Industry

Identifiers

NCT04968548

Lung-RND-003

Details and patient eligibility

About

This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

Full description

This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.

Enrollment

5,000 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Cases:

Current or past smokers, with at least 20 pack-years
Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients

Exclusion Criteria - Cases:

Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Current lung cancer is known to be stage III or IV by pathology.

Inclusion Criteria - Screening:

- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening

Exclusion Criteria - Screening:

Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Subjects whose purpose of performing LDCT is for surveillance of a lung nodule