Lung CancerNCT06245876
Lung EpiCheck Biomarkers Development Study
An observational study of Lung Cancer, run by Nucleix Ltd. at 10 sites in 4 countries.
Trial summary
This study is part of the development of a non-invasive lung cancer 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 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood collection
- How many people
- 2,132 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 17 May 2022to 31 Jan 2026
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Age 20-80 years
- Never smoker or current / previous smoker < 20 pack year history
Who cannot join
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
- Presenting with fever with body temperature 100.4°F (38°C) or higher
Show all 9Show fewer
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
- Pregnancy
- Any history of blood product transfusion within 30 days prior to blood draw
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States6 sites
Life Spring Clinical Research
Miami, Florida, 33130
Emerald Coast OBGYN
Panama City, Florida, 32405
Urology San Antonio
San Antonio, Texas, 78229
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
Comprehensive Urology
Southfield, Michigan, 48076
Michigan Institute of Urology, P.C.
Troy, Michigan, 48084
About this study
This study is part of the development of a non-invasive lung cancer 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, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
- Conditions
- Lung Cancer
- Being tested
- Blood collection
- Keywords
- Lung cancer screening
- 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 collectionOther
Blood collection
| Study group | Role | What they receive |
|---|---|---|
| Cases Cohort | Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. Receives: Other: Blood collection | |
| USPSTF At Risk - Control Cohort | Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years. Receives: Other: Blood collection | |
| Healthy Control Cohort | Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start17 May 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucleix Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245876
- Sponsor's protocol ID
- Evergreen-LNG-001
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Lung EpiCheck Biomarkers Development Study
- ClinicalTrials.gov ID
- NCT06245876
- Acronym / sponsor ID
- Evergreen-LNG-001
- Conditions
- Lung Cancer
- Keywords
- Lung cancer screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,132 participants (actual)
- Lead sponsor
- Nucleix Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 7 Feb 2024 (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 of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.
Detailed description
This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases Cohort | – | Other: Blood collectionSubjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. |
| USPSTF At Risk - Control Cohort | – | Other: Blood collectionHealthy subjects aged 50-80 years old with smoking history of at least 20 pack years. |
| Healthy Control Cohort | – | Other: Blood collectionHealthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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 (7 listed)
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
Key exclusion criteria (9 listed)
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
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 collectionBlood collection | Other | Cases Cohort, Healthy Control Cohort, USPSTF At Risk - Control Cohort |
Primary outcome
Performance
Time frame: Day 1
Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value).
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 4 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 10 sites in 4 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 7 inclusion and 9 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 10 sites in United States, Israel, Hungary, Netherlands. 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?
Performance (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.