Clinical trial NCT06245876: Lung EpiCheck Biomarkers Development Study
Official title: Lung EpiCheck Biomarkers Development Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Lung cancer screening
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility 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

Primary outcomes:
measure: Performance
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Life Spring Clinical Research
state: Florida
city: Panama City
country: United States
facility: Emerald Coast OBGYN
state: Florida
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Southfield
country: United States
facility: Comprehensive Urology
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology, P.C.
state: Michigan
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Budapest
country: Hungary
facility: National Koranyi Institute for Pulmonology
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Hengelo
country: Netherlands
facility: ZGT Medical Center
Study officials:
References: