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

November 4, 2024 updated by: Freenome Holdings Inc.

The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

788

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Cordele, Georgia, United States, 31015
        • Crisp Regional Hospital
    • Illinois
      • Orland Park, Illinois, United States, 47006
        • Silver Cross Hospital and Medical centers
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
    • Indiana
      • Batesville, Indiana, United States, 47006
        • Margaret Mary
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health Cancer Institute
      • Winona, Minnesota, United States, 55987
        • Winona Health System
    • Missouri
      • Carrollton, Missouri, United States, 64633
        • Carroll County Memorial Hospital
      • Hannibal, Missouri, United States, 63401
        • Hannibal Regional Hospital
      • Kansas City, Missouri, United States, 64108
        • University Health Truman Medical Center
      • North Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Mullica Hill, New Jersey, United States, 08062
        • Inspira Medical Center
      • Paterson, New Jersey, United States, 07503
        • St Joseph University
    • North Carolina
      • Statesville, North Carolina, United States, 28677
        • Iredell Memorial Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health and Science University
    • Pennsylvania
      • Bloomsburg, Pennsylvania, United States, 17815
        • Geisinger Bloomsburg Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
      • Florence, South Carolina, United States, 29506
        • MacLeod Center for Cancer Treatment and Research
    • Texas
      • Austin, Texas, United States, 78738
        • Elligo Health Research, Inc.
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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 preclude enrollment in the study
  • Known to be pregnant
  • Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, 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 during the 30 days preceding enrollment
  • Participated or currently participating in another Freenome-sponsored clinical study
  • For non-cancer groups: 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 groups: 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Group
  • Collect Subject Data
  • Collect Blood Specimen
Diagnostic test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
Non-cancer Group
  • Collect Subject Data
  • Collect Blood Specimen
Diagnostic test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • The Sanderson Study/FRNM-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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