NCT05254834

Brief Summary

This protocol is a case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for multiple cancers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,435

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

68 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

February 15, 2022

Last Update Submit

August 21, 2025

Conditions

Keywords

Liquid BiopsyBlood TestCancer DiagnosticGenomicsMultiomicsArtificial IntelligenceScreeningMachine LearningFreenomeEarly DetectionMulticancerCancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants

    To compare blood samples from cancer case and non-cancer control subjects in order to develop and characterize blood-based multiomics tests in specific cancer types or in a combination of multiple cancers.

    12 months

Study Arms (2)

Cancer Group

Collect Subject Data Collect Blood Specimen

Diagnostic Test: Freenome Test

Non-cancer Group

Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status

Diagnostic Test: Freenome Test

Interventions

Freenome TestDIAGNOSTIC_TEST

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.

Cancer GroupNon-cancer Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 30+ who have been newly diagnosed (treatment-naive) with cancer and Adults 30+ without cancer

You may qualify if:

  • Age at least 30 years
  • Able and willing to provide blood samples per protocol
  • Able to comprehend and willing to sign and date the informed consent documents
  • Participants must meet one of the following:
  • Diagnosed with a single primary cancer that has not yet been treated
  • No evidence or treatment of any cancer for at least 5 years prior to enrollment

You may not qualify if:

  • A medical condition which, in the opinion of the investigator, should preclude enrollment in the study
  • Known to be pregnant
  • Any therapy for cancer, including surgery, chemotherapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
  • Participated or currently participating in a clinical research study in which an experimental medication has been administered in the last 30 days
  • Participated in or currently participating in another Freenome clinical study
  • For the control cohort: Any previous cancer diagnosis in the 5 years preceding enrollment, or recurrence of the same primary cancer within any timeframe; or concurrent diagnosis of multiple primary cancers within any timeframe
  • For the cancer cohorts: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Alabama Oncology

Birmingham, Alabama, 35243, United States

Location

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

John Muir Health

Concord, California, 94520, United States

Location

Carbon Health

Corona, California, 92883, United States

Location

Miller Bioconnect

El Cajon, California, 92021, United States

Location

Gastroenterology and Liver Institute

Escondido, California, 92025, United States

Location

Women's Cancer Network

Fresno, California, 93710, United States

Location

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

Urology Alliance Clinical Research

Los Angeles, California, 90048, United States

Location

Mercy Cancer Center

Merced, California, 95340, United States

Location

Pomona Valley Hospital Medical Center/Cancer Care Center

Pomona, California, 91767, United States

Location

St. Mary's Medical Center

San Francisco, California, 94117, United States

Location

Dominican Hospital Dignity Health

Santa Cruz, California, 94520, United States

Location

Stockton Hematology Oncology

Stockton, California, 95204, United States

Location

Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505, United States

Location

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

RecioMed Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Mid Florida Hematology & Oncology Center

Orange City, Florida, 32763, United States

Location

Emerald Coast OBGYN

Panama City, Florida, 32405, United States

Location

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Cancer Center of Middle Georgia (QCCA)

Dublin, Georgia, 31021, United States

Location

Specicare

Gainesville, Georgia, 30501, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Northwest Oncology & Hematology

Rolling Meadows, Illinois, 60008, United States

Location

Objective Health Network (Digestive Research Alliance of Michiana, LLC)

South Bend, Indiana, 46635, United States

Location

Ascension Via Christi Hospital, Wichita

Wichita, Kansas, 67214, United States

Location

Saint Joseph Cancer Center

Lexington, Kentucky, 40509, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Ascension Providence Rochester Hospital

Rochester Hills, Michigan, 48309, United States

Location

Covenant HealthCare

Saginaw, Michigan, 48604, United States

Location

University of Minnesota, School of Public Health, Environmental Health Sciences

Minneapolis, Minnesota, 55455, United States

Location

Central Care Cancer Center

Bolivar, Missouri, 65613, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Logan Health Research

Kalispell, Montana, 59901, United States

Location

Cancer Care Specialists Reno

Reno, Nevada, 93710, United States

Location

Inspira Medical Center Vineland

Vineland, New Jersey, 08360, United States

Location

NYU

New York, New York, 10010, United States

Location

NY Cancer & Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

White Plains Hospital

White Plains, New York, 10601, United States

Location

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Objective Health Network

Dayton, Ohio, 45414, United States

Location

Hightower Clinical Research

Oklahoma City, Oklahoma, 73102, United States

Location

St. Charles Health System, Inc

Bend, Oregon, 97701, United States

Location

Doylestown Health

Doylestown, Pennsylvania, 18901, United States

Location

Pennsylvania Cancer Specialists & Research Institute

Gettysburg, Pennsylvania, 17325, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19141, United States

Location

Donald Guthrie Foundation

Sayre, Pennsylvania, 18840, United States

Location

USDH Clinical Research

Wyomissing, Pennsylvania, 19160, United States

Location

Cancer Care Associates of York (QCCA)

York, Pennsylvania, 17403, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

ObjectiveHealth, Inc

Franklin, Tennessee, 37067, United States

Location

Christus Spohn Shoreline Hospital

Corpus Christi, Texas, 78404, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75702, United States

Location

Centra Lynchburg Hematology Oncology

Lynchburg, Virginia, 24501, United States

Location

Objective Health Network

Richmond, Virginia, 23236, United States

Location

Northwest Medical Specialties (QCCA)

Tacoma, Washington, 98405, United States

Location

SSM Health-Dean Medical Group

Madison, Wisconsin, 53715, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 24, 2022

Study Start

February 15, 2022

Primary Completion

July 24, 2024

Study Completion

July 12, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations