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New blood test could spot lung cancer before it spreads

NCT ID NCT04968548

Diagnosis Sponsor: Nucleix Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is developing a new blood test called Lung EpiCheck® to find lung cancer early in people at high risk, like heavy smokers. Researchers will collect blood samples and medical information from 5,000 participants to see how accurate the test is. The goal is to create a simple, non-invasive screening tool that could catch lung cancer sooner, when it's easier to treat.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The Case Series will include subjects 50-80 years old, current or past smokers with at least 20 pack-years, with either (a) a high suspicion for lung cancer, who are planning to undergo surgery to establish a definitive diagnosis; or (b) confirmed lung cancer diagnosis, however did not yet undergo any treatment for this cancerous lesion. The Screening Series will include subjects 50-80 years old, current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening. All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix

Ages

50 to 80 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer

Contacts and locations

Locations

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Centura Health

    Lakewood, Colorado, 80228, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44106, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Durham VA Health Care System

    Durham, North Carolina, 27710, United States

  • Harry S. Truman Memorial Veterans' Hospital

    Columbia, Missouri, 65201, United States

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21287, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A3J1, Canada

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Novant Health Cancer Research

    Winston-Salem, North Carolina, 27103, United States

  • Orlando Health, Inc.

    Orlando, Florida, 32806, United States

  • Owensboro Health

    Owensboro, Kentucky, 42303, United States

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Scripps Memorial Hospital

    Encinitas, California, 92024, United States

  • St. Elizabeth Edgewood Hospital

    Edgewood, Kentucky, 41017, United States

  • Summa Health

    Akron, Ohio, 44304, United States

  • The University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University Health Network

    Toronto, Ontario, M5G 2C4, Canada

  • University of Calgary

    Calgary, Alberta, T2N 1N4, Canada

  • University of Minnesota Health

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06516, United States

  • Vancouver General Hospital/The University of British Columbia

    Vancouver, British Columbia, V5Z 1M9, Canada

  • W.G. (Bill) Hefner VA Medical Center

    Salisbury, North Carolina, 28144, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.