Lung Cancer DiagnosisPROACT-LUNGNCT06122077
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
An observational study of Lung Cancer Diagnosis, run by Freenome Holdings Inc. at 36 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lung Cancer Diagnosis
- What is being tested?
- blood draw
- How many people
- 20,000 participants
- Where
- 36 sitesUnited States
- Study dates
- 28 Nov 2023to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age 50 years or older within 30 days of enrollment
- Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
- Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents
Who cannot join
- Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
- History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer)
- History of organ, tissue, and bone marrow transplantation
- Screened for lung cancer or having chest CT scan 12 months before enrollment
- Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome
- Received a blood transfusion in the 30 days preceding enrollment
Show all 10Show fewer
- Known to be pregnant
- Participated or currently participating in another Freenome-sponsored clinical study
- Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days preceding enrollment
- Any condition that in the opinion of the Investigator should not be enrolled in the study
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
United States36 sites, 36 recruiting
- Recruiting
Ascension St. Agnes Hospital
Baltimore, Maryland, 21237
Study Coordinator
- Recruiting
Our Lady of Lourdes Hospital
Binghamton, New York, 13905
Study Coordinator
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Study Coordinator
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Study Coordinator
- Recruiting
Walgreens
Deerfield, Illinois, 60015
Study Coordinator
- Recruiting
Hillcrest Medical Research
DeLand, Florida, 32720
Study Coordinator
- Recruiting
Universal Axon Clinical Research
Doral, Florida, 33166
Study Coordinator
- Recruiting
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
Study Coordinator
- Recruiting
McLeod Health
Florence, South Carolina, 29506
Study Coordinator
- Recruiting
SpeciCare, Inc
Gainesville, Georgia, 30501
- Recruiting
Altru Health System
Grand Forks, North Dakota, 58201
Study Coordinator
- Recruiting
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39503
Study Coordinator
- Recruiting
Horizon Clinical Research Group
Houston, Texas, 77008
Study Coordinator
- Recruiting
Cape Cod Hospital
Hyannis, Massachusetts, 02601
Study Coordinator
- Recruiting
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Study Coordinator
- Recruiting
I.H.S Health, LLC
Kissimmee, Florida, 34741
- Recruiting
US Digestive Health at Lancaster
Lancaster, Pennsylvania, 17601
Study Coordinator
- Recruiting
Aton Health
Leawood, Kansas, 66211
Study Coordinator
- Recruiting
Science 37
Los Angeles, California, 90230
Study Coordinator
- Recruiting
Ascension Columbia St. Mary's Wisconsin
Milwaukee, Wisconsin, 53211
Study Coordinator
- Recruiting
Inspira Medical Center
Mullica Hill, New Jersey, 08062
- Recruiting
Hightower Clinical
Oklahoma City, Oklahoma, 73102
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Study Coordinator
- Recruiting
Circle Clinical Research
Pierre, South Dakota, 57104
Study Coordinator
- Recruiting
United Medical Research
Port Orange, Florida, 32127
Study Coordinator
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97201
Study Coordinator
- Recruiting
Wakemed
Raleigh, North Carolina, 27610
Study Coordinator
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
Study Coordinator
- Recruiting
Guthrie Medical Group
Sayre, Pennsylvania, 18840
Study Coordinator
- Recruiting
Springfield Clinic, LLP
Springfield, Illinois, 62702
- Recruiting
Stamford Hospital
Stamford, Connecticut, 06902
Study Coordinator
- Recruiting
Charter Research
The Villages, Florida, 32162
Study Coordinator
- Recruiting
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
Study Coordinator
- Recruiting
Ascension Via Christi Wichita
Wichita, Kansas, 67214
Study Coordinator
- Recruiting
Charter Research
Winter Park, Florida, 32792
Study Coordinator
- Recruiting
US Digestive Health at Wyomissing
Wyomissing, Pennsylvania, 19610
Study Coordinator
About this study
Official title: The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
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).
Read the 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.
- Conditions
- Lung Cancer Diagnosis
- Being tested
- blood draw
- 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
- Medical subject headings
- Lung Neoplasms, Respiratory Distress Syndrome, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity in detecting lung cancer
Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period
Measured: 12-Months
Secondary outcomes (1)
Sensitivity and specificity in detecting lung cancer
Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period
Measured: 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start28 Nov 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freenome Holdings Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Sumner, Study director, Freenome Holdings Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122077
- Sponsor's protocol ID
- FRNM-007
- Acronym
- PROACT-LUNG
- Status last verified
- Aug 2025
- First submitted
- 3 Nov 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)
- ClinicalTrials.gov ID
- NCT06122077
- Acronym / sponsor ID
- PROACT-LUNG / FRNM-007
- Conditions
- Lung Cancer Diagnosis
- Keywords
- Artificial Intelligence, Liquid Biopsy, Blood Test Cancer, Cancer Diagnostic, Genomics, Genomics Test, Multiomics, Cancer Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Freenome Holdings Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 50 years or older within 30 days of enrollment
- Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
- Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents
Key exclusion criteria (10 listed)
- Any active therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy at the time of enrollment
- History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer)
- History of organ, tissue, and bone marrow transplantation
- Screened for lung cancer or having chest CT scan 12 months before enrollment
- Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawSubjects 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. | Diagnostic test | – |
Primary outcome
Sensitivity and specificity in detecting lung cancer
Time frame: 12-Months
Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period
1 secondary outcome
Sensitivity and specificity in detecting lung cancer
Time frame: 24-Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victoria Sumner study director
Freenome Holdings Inc.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Diagnosis, run by Freenome Holdings Inc. at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harris Naemi, BS (925-322-6486, FRNM007@freenome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity in detecting lung cancer (time frame: 12-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.