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Lung EpiCheck Biomarkers Development Study | Clinical Trials | Clareo Health

UNKNOWN

Lung EpiCheck Biomarkers Development Study

NCT06245876•Nucleix Ltd.

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.

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

•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
•\- 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
•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

Locations (10)

Life Spring Clinical Research

Miami, Florida, United States

Emerald Coast OBGYN

Panama City, Florida, 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, United States

Urology San Antonio

San Antonio, Texas, United States

National Koranyi Institute for Pulmonology

Budapest, Hungary

Carmel Medical Center

Haifa, Israel

Sourasky Medical Center

Tel Aviv, Israel

ZGT Medical Center

Hengelo, Netherlands

Key Dates

Start Date

May 17, 2022

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

February 12, 2024

Enrollment

6,000

ESTIMATED participants

Conditions

Lung Cancer

Interventions

Blood collection

OTHER

Contacts

Yael Sendak

CONTACT

+972-8-9161616 yael@nucleix.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lung EpiCheck Biomarkers Development Study

Inclusion Criteria

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