Development of a non-invasive lung cancer screening test
Lung EpiCheck Biomarkers Development Study
This study is trying to create a simple blood test to help find lung cancer early in people aged 50-80 who smoke or have smoked, by looking for specific markers in their blood.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Nucleix Ltd. Industry-sponsored |
| Locations | 10 sites (Miami, Florida and 9 other locations) |
| Trial ID | NCT06245876 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a non-invasive screening test for early-stage lung cancer by collecting blood and clinical data from patients at high risk for lung cancer. It involves a multi-center approach where both lung cancer patients and control subjects will be assessed to identify biomarkers that can effectively differentiate between the two groups. The study focuses on individuals aged 50-80 who are current or former smokers with significant smoking history, as well as healthy controls aged 20-80.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50-80 who are current or former smokers with a history of at least 20 pack-years and a high suspicion of lung cancer.
Not a fit: Patients with a known diagnosis or treatment of any cancer in the past 5 years, except for specific fully resected cancers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of lung cancer, improving treatment outcomes and survival rates for high-risk patients.
How similar studies have performed: Other studies have shown promise in developing non-invasive biomarkers for lung cancer detection, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - Cases: * 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. Exclusion Criteria - Cases * 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 Inclusion Criteria - USPSTF risk * Age 50-80 years * Subjects who are currently smoking or former smokers, with at least 20 pack-years Exclusion Criteria - USPSTF risk - 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 Inclusion Criteria - Healthy controls * Age 20-80 years * Never smoker or current / previous smoker \< 20 pack year history Exclusion Criteria - Healthy Controls * 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 * 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
Where this trial is running
Miami, Florida and 9 other locations
- Life Spring Clinical Research — Miami, Florida, United States (Recruiting)
- Emerald Coast OBGYN — Panama City, Florida, United States (Recruiting)
- Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States (Recruiting)
- Comprehensive Urology — Southfield, Michigan, United States (Completed)
- Michigan Institute of Urology, P.C. — Troy, Michigan, United States (Recruiting)
- Urology San Antonio — San Antonio, Texas, United States (Recruiting)
- National Koranyi Institute for Pulmonology — Budapest, Hungary (Recruiting)
- Carmel Medical Center — Haifa, Israel (Recruiting)
- Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- ZGT Medical Center — Hengelo, Netherlands (Recruiting)
Study contacts
- Study coordinator: Yael Sendak
- Email: yael@nucleix.com
- Phone: +972-8-9161616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.