Trial Title:
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
NCT ID:
NCT06122077
Condition:
Lung Cancer Diagnosis
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Artificial Intelligence
Liquid Biopsy
Blood Test Cancer
Cancer Diagnostic
Genomics
Genomics Test
Multiomics
Cancer Screening
Cancer Early Detection Test
LDCT Screening
Lung Cancer Screening
Lung Cancer
Freenome Test
Machine Learning
Acute respiratory distress syndrome (ARDS)
Chronic obstructive pulmonary disease (COPD)
Chronic bronchitis
Emphysema
Lung nodules
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
blood draw
Description:
Subjects who provide informed consent and meet the eligibility criteria will have 50 ml
of blood collected and sent to Freenome or Freenome's designee for processing, testing,
and storage, and will then complete a standard-of-care screening LDCT.
Summary:
The PROACT LUNG study is a prospective multi-center observational study to validate a
blood-based test for the early detection of lung cancer by collecting blood samples from
high-risk participants who will undergo a routine, standard-of-care screening Low-Dose
Computed Tomography (LDCT).
Detailed description:
This is a prospective, multi-center, observational study to evaluate the performance of
the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.
Enrollment will be open to all eligible participants for screening chest CT scan as part
of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria
for this study and provide informed consent will be enrolled and blood sample collection
must be completed within 30 days of signing the informed consent. Optimally, the
screening chest CT will be completed on the same day of the study blood collection,
however up to 45 days will be allowed after study blood collection to obtain a screening
chest CT.
The study will also collect demographic data and relevant clinical data, such as medical
history, lifestyle, occupational and environmental exposure(s), family history, and
clinical laboratory data. All reports and clinical notes regarding the diagnostic tests
and procedures related to lung cancer diagnosis or lung lesion assessment, such as
histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging
reports will be collected as part of follow up to the screening chest CT scan.
All enrolled subjects will be followed prospectively from the date of the baseline
screening chest CT until a minimum of 24 months, or until a premature study endpoint
inclusive of withdrawal of consent or death.
Criteria for eligibility:
Study pop:
The study aims to enroll a representative sample of the population across the United
States including adults aged 50 years and older who have at least a 20-pack-year smoking
history and who have met the eligibility criteria defined in this protocol.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Age 50 years or older within 30 days of enrollment
2. Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
3. Able to comprehend and willing to sign and date the informed consent and HIPAA
authorization documents
Exclusion Criteria:
1. Any active therapy for cancer, including but not limited to surgery, chemotherapy,
biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
2. History of any malignancy within prior 5 years of enrollment (except for non-
melanoma skin cancer)
3. History of organ, tissue, and bone marrow transplantation
4. Screened for lung cancer or having chest CT scan 12 months before enrollment
5. Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava
syndrome, Cushing syndrome, and Pancoast syndrome
6. Received a blood transfusion in the 30 days preceding enrollment
7. Known to be pregnant
8. Participated or currently participating in another Freenome-sponsored clinical study
9. Participated or currently participating in a clinical research study in which an
experimental medication has been administered during the 60 days preceding
enrollment
10. Any condition that in the opinion of the Investigator should not be enrolled in the
study
Gender:
All
Gender based:
Yes
Gender description:
Sex assigned at birth
Minimum age:
50 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Science 37
Address:
City:
Los Angeles
Zip:
90230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Stamford Hospital
Address:
City:
Stamford
Zip:
06902
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hillcrest Medical Research
Address:
City:
DeLand
Zip:
32720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Universal Axon Clinical Research
Address:
City:
Doral
Zip:
33166
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
I.H.S Health, LLC
Address:
City:
Kissimmee
Zip:
34741
Country:
United States
Status:
Recruiting
Facility:
Name:
United Medical Research
Address:
City:
Port Orange
Zip:
32127
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Charter Research
Address:
City:
The Villages
Zip:
32162
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Charter Research
Address:
City:
Winter Park
Zip:
32792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
SpeciCare, Inc
Address:
City:
Gainesville
Zip:
30501
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Walgreens
Address:
City:
Deerfield
Zip:
60015
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Springfield Clinic, LLP
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Facility:
Name:
Aton Health
Address:
City:
Leawood
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ascension Via Christi Wichita
Address:
City:
Wichita
Zip:
67214
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ascension St. Agnes Hospital
Address:
City:
Baltimore
Zip:
21237
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Cape Cod Hospital
Address:
City:
Hyannis
Zip:
02601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Memorial Hospital at Gulfport
Address:
City:
Gulfport
Zip:
39503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Renown Regional Medical Center
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Inspira Medical Center
Address:
City:
Mullica Hill
Zip:
08062
Country:
United States
Status:
Recruiting
Facility:
Name:
Our Lady of Lourdes Hospital
Address:
City:
Binghamton
Zip:
13905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Wakemed
Address:
City:
Raleigh
Zip:
27610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Altru Health System
Address:
City:
Grand Forks
Zip:
58201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Hightower Clinical
Address:
City:
Oklahoma City
Zip:
73102
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Clinical Research Associates of Central PA
Address:
City:
DuBois
Zip:
15801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
US Digestive Health at Lancaster
Address:
City:
Lancaster
Zip:
17601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Temple University
Address:
City:
Philadelphia
Zip:
19140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Guthrie Medical Group
Address:
City:
Sayre
Zip:
18840
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
US Digestive Health at Wyomissing
Address:
City:
Wyomissing
Zip:
19610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Medical University of South Carolina (MUSC)
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
McLeod Health
Address:
City:
Florence
Zip:
29506
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Circle Clinical Research
Address:
City:
Pierre
Zip:
57104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
The Jackson Clinic, PA
Address:
City:
Jackson
Zip:
38305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
CHRISTUS Trinity Mother Frances Health System
Address:
City:
Tyler
Zip:
75701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Ascension Columbia St. Mary's Wisconsin
Address:
City:
Milwaukee
Zip:
53211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Start date:
November 28, 2023
Completion date:
June 15, 2027
Lead sponsor:
Agency:
Freenome Holdings Inc.
Agency class:
Industry
Source:
Freenome Holdings Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06122077
