Lung EpiCheck Biomarkers Development Study

NCT06245876 | Recruiting

• 1 other identifier: Evergreen-LNG-001
• Study Type: observational
• Target: 6,000
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Lung Cancer

Keywords

Lung cancer screening

Outcome Measures

Primary Outcomes (1)

• Performance

  Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value).

  Day 1

Study Arms (3)

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.

Other: Blood collection

USPSTF At Risk - Control Cohort

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

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.

Other: Blood collection

Interventions

Blood collection OTHER

Blood collection

Cases Cohort; Healthy Control Cohort; USPSTF At Risk - Control Cohort

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• Age 50-80 years
• Subjects who are currently smoking or former smokers, with at least 20 pack-years
• \- 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
• Age 20-80 years
• Never smoker or current / previous smoker \< 20 pack year history
• 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

Sponsors & Collaborators

• Nucleix Ltd.: lead

Study Sites (10)

Life Spring Clinical Research

Miami, Florida, 33130, United States

RECRUITING

Emerald Coast OBGYN

Panama City, Florida, 32405, United States

RECRUITING

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

RECRUITING

Comprehensive Urology

Southfield, Michigan, 48076, United States

COMPLETED

Michigan Institute of Urology, P.C.

Troy, Michigan, 48084, United States

RECRUITING

Urology San Antonio

San Antonio, Texas, 78229, 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

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Yael Sendak

CONTACT

+972-8-9161616; yael@nucleix.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: May 17, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); IL (2); NL (1); HU (1)