PROACT-LUNG: Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Sponsor

Freenome Holdings Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06122077

Collaborator

(none)

20,000

Enrollment

Locations

Anticipated Duration (Months)

5000

Patients Per Site

116.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Diagnosis	Diagnostic Test: blood draw

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

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Jun 15, 2026

Anticipated Study Completion Date :

Jun 15, 2027

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity in detecting lung cancer [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

Secondary Outcome Measures

Sensitivity and specificity in detecting lung cancer [24-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 24-month follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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 2 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 16 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
Known to be pregnant
Participated or currently participating in another Freenome-sponsored clinical study
Any condition that in the opinion of the Investigator should not be enrolled in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	I.H.S Health, LLC	Kissimmee	Florida	United States	34741
2	SpeciCare, Inc	Gainesville	Georgia	United States	30501
3	Walgreens	Deerfield	Illinois	United States	60015
4	Springfield Clinic, LLP	Springfield	Illinois	United States	62702