RECRUITING

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

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Conditions

Lung Cancer DiagnosisArtificial IntelligenceLiquid BiopsyBlood Test CancerCancer DiagnosticGenomicsGenomics TestMultiomicsCancer ScreeningCancer Early Detection TestLDCT ScreeningLung Cancer ScreeningLung CancerFreenome TestMachine LearningAcute respiratory distress syndrome (ARDS)Chronic obstructive pulmonary disease (COPD)Chronic bronchitisEmphysemaLung nodules

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-11-28
Study Completion:2027-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06122077

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 50 years or older within 30 days of enrollment
  2. 2. Current or former smokers with a cumulative smoking history of ≥ 20 pack-year
  3. 3. Able to comprehend and willing to sign and date the informed consent and HIPAA authorization documents
  1. 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. 2. History of any malignancy within prior 5 years of enrollment (except for non- melanoma skin cancer)
  3. 3. History of organ, tissue, and bone marrow transplantation
  4. 4. Screened for lung cancer or having chest CT scan 12 months before enrollment
  5. 5. Having signs and symptoms of lung cancer such as hemoptysis, superior vena cava syndrome, Cushing syndrome, and Pancoast syndrome
  6. 6. Received a blood transfusion in the 30 days preceding enrollment
  7. 7. Known to be pregnant
  8. 8. Participated or currently participating in another Freenome-sponsored clinical study
  9. 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. 10. Any condition that in the opinion of the Investigator should not be enrolled in the study

Contacts and Locations

Study Contact

April Allison, BS
CONTACT
925-322-6486
FRNM007@freenome.com
Harris Naemi, BS / Joye Choy, BS
CONTACT
925-322-6486
FRNM007@freenome.com

Principal Investigator

Chuanbo Xu, PhD
STUDY_DIRECTOR
Freenome Holdings Inc.

Study Locations (Sites)

Science 37
Los Angeles, California, 90230
United States
Stamford Hospital
Stamford, Connecticut, 06902
United States
Hillcrest Medical Research
DeLand, Florida, 32720
United States
Universal Axon Clinical Research
Doral, Florida, 33166
United States
I.H.S Health, LLC
Kissimmee, Florida, 34741
United States
United Medical Research
Port Orange, Florida, 32127
United States
Charter Research
The Villages, Florida, 32162
United States
Charter Research
Winter Park, Florida, 32792
United States
SpeciCare, Inc
Gainesville, Georgia, 30501
United States
University of Chicago
Chicago, Illinois, 60637
United States
Walgreens
Deerfield, Illinois, 60015
United States
Springfield Clinic, LLP
Springfield, Illinois, 62702
United States
Aton Health
Leawood, Kansas, 66211
United States
Ascension Via Christi Wichita
Wichita, Kansas, 67214
United States
Ascension St. Agnes Hospital
Baltimore, Maryland, 21237
United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601
United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39503
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Inspira Medical Center
Mullica Hill, New Jersey, 08062
United States
Our Lady of Lourdes Hospital
Binghamton, New York, 13905
United States
Wakemed
Raleigh, North Carolina, 27610
United States
Altru Health System
Grand Forks, North Dakota, 58201
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Oregon Health & Science University
Portland, Oregon, 97201
United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, 15801
United States
US Digestive Health at Lancaster
Lancaster, Pennsylvania, 17601
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Guthrie Medical Group
Sayre, Pennsylvania, 18840
United States
US Digestive Health at Wyomissing
Wyomissing, Pennsylvania, 19610
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
United States
McLeod Health
Florence, South Carolina, 29506
United States
Circle Clinical Research
Pierre, South Dakota, 57104
United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305
United States
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
United States
Ascension Columbia St. Mary's Wisconsin
Milwaukee, Wisconsin, 53211
United States

Collaborators and Investigators

Sponsor: Freenome Holdings Inc.

  • Chuanbo Xu, PhD, STUDY_DIRECTOR, Freenome Holdings Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28
Study Completion Date2027-06-15

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2027-06-15

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Lung Cancer Diagnosis