NCT06122077

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Freenome Holdings Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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.

Conditions

• Lung Cancer Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood draw	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.

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-06-15
• Completion: 2027-06-15
• First posted: 2023-11-08
• Last updated: 2025-08-05

Locations

36 sites across 1 country: United States