Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Description

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).

Conditions

Lung Cancer Diagnosis

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Study Overview

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Study Details

Study overview

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).

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

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

Condition
Lung Cancer Diagnosis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Science 37, Los Angeles, California, United States, 90230

Stamford

Stamford Hospital, Stamford, Connecticut, United States, 06902

DeLand

Hillcrest Medical Research, DeLand, Florida, United States, 32720

Doral

Universal Axon Clinical Research, Doral, Florida, United States, 33166

Kissimmee

I.H.S Health, LLC, Kissimmee, Florida, United States, 34741

Port Orange

United Medical Research, Port Orange, Florida, United States, 32127

The Villages

Charter Research, The Villages, Florida, United States, 32162

Winter Park

Charter Research, Winter Park, Florida, United States, 32792

Gainesville

SpeciCare, Inc, Gainesville, Georgia, United States, 30501

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Freenome Holdings Inc.,

Chuanbo Xu, PhD, STUDY_DIRECTOR, Freenome Holdings Inc.

Study Record Dates

2027-06-15