Biomarker Screening Test for Lung Cancer

Recruiting at 8 trial locations

Overseen By Yael Sendak

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nucleix Ltd.

Disqualifiers: Recent cancer, Pregnancy, Fever, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a simple test to detect lung cancer early in high-risk individuals. It involves three groups: healthy individuals with little to no smoking history, those with a significant smoking history who are healthy, and those suspected or confirmed to have lung cancer. Suitable candidates for the trial include individuals aged 50 to 80 who have smoked heavily and are concerned about lung cancer. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could lead to earlier detection of lung cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this screening test is safe for lung cancer detection?

Research has shown that Lung EpiCheck is generally easy for patients to handle. It is a simple blood test that detects DNA from lung tumors. No major safety issues have been reported, suggesting it is safe for patients. The test has been used successfully in both Europe and China to predict lung cancer. Although no test is entirely without risk, current evidence suggests it is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lung EpiCheck Biomarkers Development Study because it aims to refine how we detect lung cancer, especially in high-risk populations. Unlike traditional methods that rely on imaging and invasive biopsies, this study explores a non-invasive approach using biomarker analysis. By identifying specific biomarkers in the blood or other bodily fluids, this method could potentially provide earlier and more accurate detection of lung cancer, making it a game-changer in early diagnosis and treatment planning. This could lead to quicker interventions and improved outcomes for those at risk or suspected of having lung cancer.

What evidence suggests that the Lung EpiCheck is effective for lung cancer screening?

Research has shown that Lung EpiCheck, a non-invasive screening test, holds promise for detecting early-stage lung cancer. Studies have found that it identifies lung cancer with high sensitivity, effectively detecting the disease in its early stages. Tests conducted in Europe and China demonstrated Lung EpiCheck's strong performance in predicting lung cancer. Early detection is crucial, as it significantly increases the chances of successful treatment, with survival rates up to 10 times higher compared to later-stage detection. This trial will evaluate Lung EpiCheck's effectiveness in different cohorts, including those at high risk for lung cancer. These findings suggest that Lung EpiCheck could be a valuable tool for early lung cancer detection, particularly for high-risk individuals. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 50 and 80 years old.

I am suspected to have lung cancer and will undergo a biopsy or surgery soon, or I have confirmed lung cancer but haven't started treatment.

I have smoked at least 20 pack-years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Blood and clinical data are collected from participants to characterize biomarkers

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lung EpiCheck

How Is the Trial Designed?

Group I: USPSTF At Risk - Control Cohort Experimental Treatment 1 Intervention

Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years.

Group II: Healthy Control Cohort Experimental Treatment 1 Intervention

Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years.

Group III: Cases Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nucleix Ltd.

Lead Sponsor

Trials

10

Recruited

15,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7806969/

Validation of Lung EpiCheck, a novel methylation-based ... Lung EpiCheck demonstrated strong performance in lung cancer prediction in case–control European and Chinese samples, detecting high proportions ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06245876

Lung EpiCheck Biomarkers Development 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 ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)05233-9/fulltext

ENHANCED DETECTION OF EARLY-STAGE LUNG ... Our preliminary findings show the potential of Lung EpiCheck to detect early-stage lung cancer with high sensitivity.

4. nucleix.com nucleix.com/lung-epicheck/

Lung EpiCheck Most patients are currently diagnosed with late-stage cancer, though research has shown 5-year survival rates are up to 10 times greater when disease is ...

5. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00413-4/fulltext

Biomarker trajectory for earlier detection of lung cancer ∙ et al. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy.

6. chestpulmonary.org chestpulmonary.org/article/S2949-7892(24)00036-9/fulltext

Liquid Markers for Risk Stratification of Pulmonary Nodules ... In cell-free DNA, Lung EpiCheck (Nucleix) detects lung cancer ... detection of lung cancer in European and Chinese high-risk individuals.