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 lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Blood collection

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 Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Yael Sendak; Phone Number: +972-8-9161616; Email: yael@nucleix.com

Study Locations

• Hungary
  • Budapest, Hungary
    • Recruiting
    • National Koranyi Institute for Pulmonology
• Israel
  • Haifa, Israel
    • Recruiting
    • Carmel Medical Center
  • Tel Aviv, Israel
    • Recruiting
    • Sourasky Medical Center
• Netherlands
  • Hengelo, Netherlands
    • Recruiting
    • ZGT Medical Center
• United States
  • Florida
    • Miami, Florida, United States, 33130
      • Recruiting
      • Life Spring Clinical Research
    • Panama City, Florida, United States, 32405
      • Recruiting
      • Emerald Coast ObGyn
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Recruiting
      • Ochsner LSU Health Shreveport - Regional Urology
  • Michigan
    • Southfield, Michigan, United States, 48076
      • Completed
      • Comprehensive Urology
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Michigan Institute of Urology, P.C.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; Blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nucleix Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung cancer screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Evergreen-LNG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No