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NCT06245876 | RECRUITING | Lung Cancer

Lung EpiCheck Biomarkers Development Study
Sponsor:

Nucleix Ltd.

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.

Condition or disease

Lung Cancer

Intervention/treatment

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
Estimated Enrollment : 6000 participants
Official Title : Lung EpiCheck Biomarkers Development Study
Actual Study Start Date : 2022-05-17
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
    • Lung EpiCheck Biomarkers Development Study

    Location Details

    NCT06245876

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Florida

    Life Spring Clinical Research

    Miami, Florida, United States, 33130

    RECRUITING

    United States, Florida

    Emerald Coast OBGYN

    Panama City, Florida, United States, 32405

    RECRUITING

    United States, Louisiana

    Ochsner LSU Health Shreveport - Regional Urology

    Shreveport, Louisiana, United States, 71106

    COMPLETED

    United States, Road cancer

    Comprehensive Urology

    Southfield, Road cancer, United States, 48076

    RECRUITING

    United States, Road cancer

    Michigan Institute of Urology, P.C.

    Troy, Road cancer, United States, 48084

    RECRUITING

    United States, Texas

    Urology San Antonio

    San Antonio, Texas, United States, 78229

    RECRUITING

    Hungary,

    National Karanyi Institute for Pulmonology

    Budapest, Hungary,

    RECRUITING

    Israel,

    Carmel Medical Center

    Haifa, Israel,

    RECRUITING

    Israel,

    Sourasky Medical Center

    Tel Aviv, Israel,

    RECRUITING

    Netherlands,

    ZGT Medical Center

    Hengelo, Netherlands,