Lung CancerNCT04968548
Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
An observational study of Lung Cancer, run by Nucleix Ltd. at 31 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 6,182 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 17 Sep 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening
Who cannot join
- 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.
- 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
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States27 sites
Summa Health
Akron, Ohio, 44304
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
The University of North Carolina
Chapel Hill, North Carolina, 27599
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44106
Harry S. Truman Memorial Veterans' Hospital
Columbia, Missouri, 65201
Duke University
Durham, North Carolina, 27705
Durham VA Health Care System
Durham, North Carolina, 27710
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, 41017
Scripps Memorial Hospital
Encinitas, California, 92024
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Centura Health
Lakewood, Colorado, 80228
Norton Cancer Institute
Louisville, Kentucky, 40202
Baptist Cancer Center
Memphis, Tennessee, 38120
University of Minnesota Health
Minneapolis, Minnesota, 55455
Northwell Health
New Hyde Park, New York, 11040
Orlando Health, Inc.
Orlando, Florida, 32806
Owensboro Health
Owensboro, Kentucky, 42303
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Rochester
Rochester, New York, 14627
W.G. (Bill) Hefner VA Medical Center
Salisbury, North Carolina, 28144
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Washington University in St. Louis
St Louis, Missouri, 63110
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Novant Health Cancer Research
Winston-Salem, North Carolina, 27103
Canada4 sites
University of Calgary
Calgary, Alberta, T2N 1N4
McGill University Health Centre
Montreal, Quebec, H4A3J1
University Health Network
Toronto, Ontario, M5G 2C4
Vancouver General Hospital/The University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Blood collection
- Keywords
- LDCT, Low Dose CT, Lung Cancer Screening, liquid biopsy, early detection, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Peripheral blood will be collected via routine venipuncture procedure
| Study group | Role | What they receive |
|---|---|---|
| Cases Series | Subjects with confirmed lung cancer diagnosis Receives: Procedure: Blood collection | |
| Screening Series | Subjects undergoing LDCT for lung cancer screening Receives: Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood samples
Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Measured: 24 Months
Clinical data collection
Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening
Measured: 24 Months
Secondary outcomes (5)
Performance
Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value)
Measured: 36 Months
Sensitivity
Performance of the assay in terms of Sensitivity
Measured: 36 Months
Specificity
Performance of the assay in terms of Specificity
Measured: 36 Months
Negative Predictive Value
Performance of the assay in terms of NPV (negative predictive value)
Measured: 36 Months
Positive Predictive Value
Performance of the assay in terms of PPV (positive predictive value)
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start17 Sep 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Radha Duttagupta, PhD, Study director, Nucleix Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968548
- Sponsor's protocol ID
- Lung-RND-003
- Status last verified
- Sep 2026
- First submitted
- 4 Jul 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan.
PubMed 33122336
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
- ClinicalTrials.gov ID
- NCT04968548
- Acronym / sponsor ID
- Lung-RND-003
- Conditions
- Lung Cancer
- Keywords
- LDCT, Low Dose CT, Lung Cancer Screening, liquid biopsy, early detection, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,182 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases Series | – | Procedure: Blood collectionSubjects with confirmed lung cancer diagnosis |
| Screening Series | – | Procedure: Blood collectionSubjects undergoing LDCT for lung cancer screening |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
- Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening
Key exclusion criteria (4 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionPeripheral blood will be collected via routine venipuncture procedure | Procedure or surgery | Cases Series, Screening Series |
Primary outcome
Collection of blood samples
Time frame: 24 Months
Collect blood to support the development and validation of a multi analyte test for lung cancer screening
Clinical data collection
Time frame: 24 Months
Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening
5 secondary outcomes
Performance
Time frame: 36 Months
Sensitivity
Time frame: 36 Months
Specificity
Time frame: 36 Months
Negative Predictive Value
Time frame: 36 Months
Positive Predictive Value
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 33122336Gaga M, Chorostowska-Wynimko J, Horvath I, Tammemagi MC, Shitrit D, Eisenberg VH, Liang H, Stav D, Levy Faber D, Jansen M, Raviv Y, Panagoulias V, Rudzinski P, Izbicki G, Ronen O, Goldhaber A, Moalem R, Arber N, Haas I, Zhou Q. Validation of Lung EpiCheck, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals. Eur Respir J. 2021 Jan 14;57(1):2002682. doi: 10.1183/13993003.02682-2020. Print 2021 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha Duttagupta, PhD study director
Nucleix Ltd.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Nucleix Ltd. at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of blood samples (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.