Lung EpiCheck Biomarkers Development Study
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
Life Spring Clinical Research
RECRUITING
Miami
Emerald Coast OBGYN
RECRUITING
Panama City
Louisiana
Ochsner LSU Health Shreveport - Regional Urology
RECRUITING
Shreveport
Michigan
Comprehensive Urology
COMPLETED
Southfield
Michigan Institute of Urology, P.C.
RECRUITING
Troy
Texas
Urology San Antonio
RECRUITING
San Antonio
Other Locations
Hungary
National Koranyi Institute for Pulmonology
RECRUITING
Budapest
Israel
Carmel Medical Center
RECRUITING
Haifa
Sourasky Medical Center
RECRUITING
Tel Aviv
Netherlands
ZGT Medical Center
RECRUITING
Hengelo
Contact Information
Primary
Yael Sendak
yael@nucleix.com
+972-8-9161616
Time Frame
Start Date: 2022-05-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 6000
Treatments
Cases Cohort
Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects.
USPSTF At Risk - Control Cohort
Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years.
Healthy Control Cohort
Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years.
Related Therapeutic Areas
Sponsors
Leads: Nucleix Ltd.