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.
Conditions:
🦠 Lung Cancer
🗓️ Study Start (Actual) 17 May 2022
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 6000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Miami, Florida, United States
📍 Panama City, Florida, United States
📍 Shreveport, Louisiana, United States
📍 Southfield, Michigan, United States
📍 Troy, Michigan, United States
📍 San Antonio, Texas, United States
📍 Budapest, Hungary
📍 Haifa, Israel
📍 Tel Aviv, Israel
📍 Hengelo, Netherlands

📋 Eligibility Criteria

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
Ages Eligible for Study: 20 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 January 2024
  • First Submitted that Met QC Criteria 30 January 2024
  • First Posted 7 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 February 2024
  • Last Update Posted 12 February 2024
  • Last Verified February 2024