The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Last updated: November 4, 2024
Sponsor: Freenome Holdings Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Freenome Test

Clinical Study ID

NCT05516927
The Sanderson Study/FRNM-006
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Age ≥30 years within 30 days of enrollment

  • Able and willing to provide blood samples per protocol

  • Able to comprehend and willing to sign and date the informed consent and HIPAA

  • Authorization documents

  • Able and willing to allow existing health data to be utilized for study purposes

Exclusion

Key Exclusion Criteria:

  • Any history of solid organ or bone marrow transplantation

  • Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment

  • Received a blood transfusion in the 30 days preceding enrollment

  • A medical condition that, in the opinion of the Investigator, should precludeenrollment in the study

  • Known to be pregnant

  • Any therapy for cancer, including but not limited to surgery, chemotherapy, biologictherapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment

  • Participated or currently participating in a clinical research study in which anexperimental medication has been administered during the 30 days precedingenrollment

  • Participated or currently participating in another Freenome-sponsored clinical study

  • For non-cancer groups: Any previous cancer diagnosis in the 5 years precedingenrollment; OR recurrence of the same primary cancer within any timeframe; ORconcurrent diagnosis of multiple primary cancers within any timeframe

  • For the cancer groups: Any previous cancer diagnosis in the 5 years precedingenrollment, apart from the current cancer diagnosis; OR recurrence of the sameprimary cancer within any timeframe; OR concurrent diagnosis of multiple primarycancers within any timeframe

Study Design

Total Participants: 788
Treatment Group(s): 1
Primary Treatment: Freenome Test
Phase:
Study Start date:
September 06, 2022
Estimated Completion Date:
May 02, 2024

Connect with a study center

  • Crisp Regional Hospital

    Cordele, Georgia 31015
    United States

    Site Not Available

  • Silver Cross Hospital and Medical centers

    Orland Park, Illinois 47006
    United States

    Site Not Available

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Margaret Mary

    Batesville, Indiana 47006
    United States

    Site Not Available

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Allina Health Cancer Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Winona Health System

    Winona, Minnesota 55987
    United States

    Site Not Available

  • Carroll County Memorial Hospital

    Carrollton, Missouri 64633
    United States

    Site Not Available

  • Hannibal Regional Hospital

    Hannibal, Missouri 63401
    United States

    Site Not Available

  • University Health Truman Medical Center

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Inspira Medical Center

    Mullica Hill, New Jersey 08062
    United States

    Site Not Available

  • St Joseph University

    Paterson, New Jersey 07503
    United States

    Site Not Available

  • Iredell Memorial Hospital

    Statesville, North Carolina 28677
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97201
    United States

    Site Not Available

  • Geisinger Bloomsburg Hospital

    Bloomsburg, Pennsylvania 17815
    United States

    Site Not Available

  • MUSC

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • MacLeod Center for Cancer Treatment and Research

    Florence, South Carolina 29506
    United States

    Site Not Available

  • Elligo Health Research, Inc.

    Austin, Texas 78738
    United States

    Site Not Available

  • INOVA

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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