Clinical trial NCT06122077: Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
Official title: The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer Diagnosis
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
Lead sponsor: Freenome Holdings Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 20000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity in detecting lung cancer
timeFrame: 12-Months
Secondary outcomes:
measure: Sensitivity and specificity in detecting lung cancer
timeFrame: 24-Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Science 37
state: California
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Kissimmee
country: United States
facility: I.H.S Health, LLC
state: Florida
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: The Villages
country: United States
facility: Charter Research
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Gainesville
country: United States
facility: SpeciCare, Inc
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Deerfield
country: United States
facility: Walgreens
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Leawood
country: United States
facility: Aton Health
state: Kansas
city: Wichita
country: United States
facility: Ascension Via Christi Wichita
state: Kansas
city: Baltimore
country: United States
facility: Ascension St. Agnes Hospital
state: Maryland
city: Hyannis
country: United States
facility: Cape Cod Hospital
state: Massachusetts
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Mullica Hill
country: United States
facility: Inspira Medical Center
state: New Jersey
city: Binghamton
country: United States
facility: Our Lady of Lourdes Hospital
state: New York
city: Raleigh
country: United States
facility: Wakemed
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA
state: Pennsylvania
city: Lancaster
country: United States
facility: US Digestive Health at Lancaster
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group
state: Pennsylvania
city: Wyomissing
country: United States
facility: US Digestive Health at Wyomissing
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Florence
country: United States
facility: McLeod Health
state: South Carolina
city: Pierre
country: United States
facility: Circle Clinical Research
state: South Dakota
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Houston
country: United States
facility: Horizon Clinical Research Group
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Mother Frances Health System
state: Texas
city: Milwaukee
country: United States
facility: Ascension Columbia St. Mary's Wisconsin
state: Wisconsin
Study officials:
affiliation: Freenome Holdings Inc.
name: Victoria Sumner
role: STUDY_DIRECTOR
References: