- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516927
The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
April 26, 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
8000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Victoria Sumner
- Phone Number: 650 676 9240
- Email: victoria.sumner@freenome.com
Study Locations
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Georgia
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Cordele, Georgia, United States, 31015
- Recruiting
- Crisp Regional Hospital
-
Contact:
- Study coordinator
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Illinois
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Orland Park, Illinois, United States, 47006
- Recruiting
- Silver Cross Hospital and Medical centers
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Contact:
- Study coordinator
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Indiana
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Batesville, Indiana, United States, 47006
- Recruiting
- Margaret Mary
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Contact:
- Study coordinator
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Minnesota
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Winona, Minnesota, United States, 55987
- Recruiting
- Winona Health System
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Contact:
- Study coordinator
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Missouri
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Carrollton, Missouri, United States, 64633
- Recruiting
- Carroll County Memorial Hospital
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Contact:
- Study coordinator
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Hannibal, Missouri, United States, 63401
- Recruiting
- Hannibal Regional Hospital
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Contact:
- Study coordinator
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Kansas City, Missouri, United States, 64108
- Recruiting
- University Health Truman Medical Center
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Contact:
- Study coordinator
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North Kansas City, Missouri, United States, 64116
- Recruiting
- North Kansas City Hospital
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Contact:
- Study coordinator
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Nevada
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Reno, Nevada, United States, 89502
- Recruiting
- Renown Regional Medical Center
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Contact:
- Study coordinator
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New Jersey
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Mullica Hill, New Jersey, United States, 08062
- Recruiting
- Inspira Medical Center
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Contact:
- Study coordinator
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Paterson, New Jersey, United States, 07503
- Recruiting
- St Joseph University
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Contact:
- Study coordinator
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North Carolina
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Statesville, North Carolina, United States, 28677
- Recruiting
- Iredell Memorial Hospital
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Contact:
- Study coordinator
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Oregon
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Portland, Oregon, United States, 97201
- Recruiting
- Oregon Health and Science University
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Contact:
- Study coordinator
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Pennsylvania
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Bloomsburg, Pennsylvania, United States, 17815
- Recruiting
- Geisinger Bloomsburg Hospital
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Contact:
- Study coordinator
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South Carolina
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Florence, South Carolina, United States, 29506
- Recruiting
- MacLeod Center for Cancer Treatment and Research
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Contact:
- Study coordinator
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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
|
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
|
Non-cancer Group
|
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
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 (Estimated)
September 6, 2024
Study Completion (Estimated)
September 6, 2025
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)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 26, 2024
Last Verified
April 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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