Lung Cancer
Conditions
Keywords
Lung cancer screening
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.
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.
Interventions
OTHERBlood collection
Blood collection
Sponsors
Nucleix Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance | Day 1 | Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value). |
Countries
Hungary, Israel, Netherlands, United States
Contacts
Primary ContactYael Sendak
Outcome results
None listed