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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516927
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Newly-diagnosed Cancers Non-cancer Controls Diagnostic Test: Freenome Test

Study Design
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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting
Actual Study Start Date : September 6, 2022
Estimated Primary Completion Date : September 6, 2024
Estimated Study Completion Date : September 6, 2025
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516927


Contacts
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Contact: Akim Lekuti (224)-321-8198 akim.lekuti@freenome.com

Locations
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United States, Georgia
Crisp Regional Hospital Recruiting
Cordele, Georgia, United States, 31015
Contact: Study Coordinator         
United States, Illinois
Silver Cross Hospital and Medical centers Recruiting
Orland Park, Illinois, United States, 47006
Contact: Study Coordinator         
United States, Indiana
Margaret Mary Recruiting
Batesville, Indiana, United States, 47006
Contact: Study Coordinator         
United States, Minnesota
Winona Health System Recruiting
Winona, Minnesota, United States, 55987
Contact: Study Coordinator         
United States, Missouri
Carroll County Memorial Hospital Recruiting
Carrollton, Missouri, United States, 64633
Contact: Study Coordinator         
Hannibal Regional Hospital Recruiting
Hannibal, Missouri, United States, 63401
Contact: Study Coordinator         
University Health Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Contact: Study Coordinator         
North Kansas City Hospital Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Study Coordinator         
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Study Coordinator         
United States, New Jersey
Inspira Medical Center Recruiting
Mullica Hill, New Jersey, United States, 08062
Contact: Study Coordinator         
St Joseph University Recruiting
Paterson, New Jersey, United States, 07503
Contact: Study Coordinator         
United States, North Carolina
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Study Coordinator         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Study Coordinator         
United States, Pennsylvania
Geisinger Bloomsburg Hospital Recruiting
Bloomsburg, Pennsylvania, United States, 17815
Contact: Study Coordinator         
United States, South Carolina
MacLeod Center for Cancer Treatment and Research Recruiting
Florence, South Carolina, United States, 29506
Contact: Study Coordinator         
Sponsors and Collaborators
Freenome Holdings Inc.
More Information
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Responsible Party: Freenome Holdings Inc.
ClinicalTrials.gov Identifier: NCT05516927    
Other Study ID Numbers: The Sanderson Study/FRNM-006
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Freenome Holdings Inc.:
Liquid Biopsy
Blood Test
Cancer Diagnostic
Genomics
Multiomics
Artificial Intelligence
 Screening
Machine Learning
Freenome
Early Detection
Multicancer