The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting
1 other identifier
observational
788
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2024
CompletedNovember 6, 2024
November 1, 2024
1.3 years
August 24, 2022
November 4, 2024
Conditions
Keywords
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
Non-cancer Group
* Collect Subject Data * Collect Blood Specimen
Interventions
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
Eligibility Criteria
* Adults 30+ who have been newly diagnosed with cancer and treatment-naive * Adults 30+ without cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Crisp Regional Hospital
Cordele, Georgia, 31015, United States
Silver Cross Hospital and Medical centers
Orland Park, Illinois, 47006, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Margaret Mary
Batesville, Indiana, 47006, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407, United States
Winona Health System
Winona, Minnesota, 55987, United States
Carroll County Memorial Hospital
Carrollton, Missouri, 64633, United States
Hannibal Regional Hospital
Hannibal, Missouri, 63401, United States
University Health Truman Medical Center
Kansas City, Missouri, 64108, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Inspira Medical Center
Mullica Hill, New Jersey, 08062, United States
St Joseph University
Paterson, New Jersey, 07503, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
Geisinger Bloomsburg Hospital
Bloomsburg, Pennsylvania, 17815, United States
MUSC
Charleston, South Carolina, 29425, United States
MacLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506, United States
Elligo Health Research, Inc.
Austin, Texas, 78738, United States
INOVA
Fairfax, Virginia, 22031, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Biospecimen
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 26, 2022
Study Start
September 6, 2022
Primary Completion
December 20, 2023
Study Completion
May 2, 2024
Last Updated
November 6, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share