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

Purpose

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.

Condition

  • Lung Cancer

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Cases Series Subjects with confirmed lung cancer diagnosis
  • Procedure: Blood collection
    Peripheral blood will be collected via routine venipuncture procedure
Screening Series Subjects undergoing LDCT for lung cancer screening
  • Procedure: Blood collection
    Peripheral blood will be collected via routine venipuncture procedure

Recruiting Locations

More Details

NCT ID
NCT04968548
Status
Active, not recruiting
Sponsor
Nucleix Ltd.

Detailed 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.