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A new blood test for early detection of lung cancer

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study

Observational Nucleix Ltd. · NCT04968548

This study is testing a new blood test to see if it can help find lung cancer early in people who are at high risk.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages50 Years to 80 Years
SexAll
SponsorNucleix Ltd. Industry-sponsored
Locations31 sites (Encinitas, California and 30 other locations)
Trial IDNCT04968548 on ClinicalTrials.gov

What this trial studies

This observational study focuses on developing and validating a non-invasive blood test aimed at identifying early-stage lung cancer in high-risk patients. It involves collecting blood and clinical data from individuals undergoing Low Dose CT (LDCT) for lung cancer screening, as well as from patients with confirmed lung cancer. The study is designed as a prospective, case-control, multi-center approach to enhance early detection methods for lung cancer.

Who should consider this trial

Good fit: Ideal candidates include current or past smokers with a significant smoking history who are undergoing LDCT for lung cancer screening.

Not a fit: Patients with a known diagnosis of stage III or IV lung cancer or those who have had any cancer treatment in the past five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of lung cancer, improving treatment outcomes for patients.

How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Encinitas, California and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung CancerLDCTLow Dose CTLung Cancer Screeningliquid biopsyearly detectionlung cancer
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.