Lung EpiCheck Biomarkers Development Study

Lung Cancer Clinical Trial

Official title:

Lung EpiCheck Biomarkers Development Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245876
• Other study ID #: Evergreen-LNG-001
• Status: Recruiting
• Start date: May 17, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Nucleix Ltd.
• Contact: Yael Sendak
• Phone: +972-8-9161616
• Email: yael[@]nucleix.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Blood collection
Blood collection

Locations

Country	Name	City	State
Hungary	National Koranyi Institute for Pulmonology	Budapest
Israel	Carmel Medical Center	Haifa
Israel	Sourasky Medical Center	Tel Aviv
Netherlands	ZGT Medical Center	Hengelo
United States	Life Spring Clinical Research	Miami	Florida
United States	Emerald Coast OBGYN	Panama City	Florida
United States	Urology San Antonio	San Antonio	Texas
United States	Ochsner LSU Health Shreveport - Regional Urology	Shreveport	Louisiana
United States	Comprehensive Urology	Southfield	Michigan
United States	Michigan Institute of Urology, P.C.	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nucleix Ltd.

Countries where clinical trial is conducted

United States,  Hungary,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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