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Trial Title:
Lung EpiCheck Biomarkers Development Study
NCT ID:
NCT06245876
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung cancer screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood collection
Description:
Blood collection
Arm group label:
Cases Cohort
Arm group label:
Healthy Control Cohort
Arm group label:
USPSTF At Risk - Control Cohort
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Life Spring Clinical Research
Address:
City:
Miami
Zip:
33130
Country:
United States
Status:
Recruiting
Facility:
Name:
Emerald Coast OBGYN
Address:
City:
Panama City
Zip:
32405
Country:
United States
Status:
Recruiting
Facility:
Name:
Ochsner LSU Health Shreveport - Regional Urology
Address:
City:
Shreveport
Zip:
71106
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Urology
Address:
City:
Southfield
Zip:
48076
Country:
United States
Status:
Completed
Facility:
Name:
Michigan Institute of Urology, P.C.
Address:
City:
Troy
Zip:
48084
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
National Koranyi Institute for Pulmonology
Address:
City:
Budapest
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Carmel Medical Center
Address:
City:
Haifa
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sourasky Medical Center
Address:
City:
Tel Aviv
Country:
Israel
Status:
Recruiting
Facility:
Name:
ZGT Medical Center
Address:
City:
Hengelo
Country:
Netherlands
Status:
Recruiting
Start date:
May 17, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Nucleix Ltd.
Agency class:
Industry
Source:
Nucleix Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245876
