Newly-diagnosed CancersNCT05516927
The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
An observational study of Newly-diagnosed Cancers and Non-cancer Controls, run by Freenome Holdings Inc. at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Newly-diagnosed Cancers, Non-cancer Controls
- What is being tested?
- Freenome Test
- How many people
- 788 participants
- Where
- 23 sitesUnited States
- Study dates
- 6 Sep 2022to 2 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Adults 30+ who have been newly diagnosed with cancer and treatment-naive * Adults 30+ without cancer
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Elligo Health Research, Inc.
Austin, Texas, 78738
Margaret Mary
Batesville, Indiana, 47006
Geisinger Bloomsburg Hospital
Bloomsburg, Pennsylvania, 17815
Carroll County Memorial Hospital
Carrollton, Missouri, 64633
MUSC
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Crisp Regional Hospital
Cordele, Georgia, 31015
Henry Ford Health
Detroit, Michigan, 48202
INOVA
Fairfax, Virginia, 22031
MacLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506
Hannibal Regional Hospital
Hannibal, Missouri, 63401
University Health Truman Medical Center
Kansas City, Missouri, 64108
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
Inspira Medical Center
Mullica Hill, New Jersey, 08062
North Kansas City Hospital
North Kansas City, Missouri, 64116
Silver Cross Hospital and Medical centers
Orland Park, Illinois, 47006
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
St Joseph University
Paterson, New Jersey, 07503
Oregon Health and Science University
Portland, Oregon, 97201
Renown Regional Medical Center
Reno, Nevada, 89502
Iredell Memorial Hospital
Statesville, North Carolina, 28677
Winona Health System
Winona, Minnesota, 55987
About this study
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
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.
- Conditions
- Newly-diagnosed Cancers, Non-cancer Controls
- Being tested
- Freenome Test
- Keywords
- Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning, Freenome, Early Detection, Multicancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freenome TestDiagnostic test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Group | * Collect Subject Data
* Collect Blood Specimen Receives: Diagnostic Test: Freenome Test | |
| Non-cancer Group | * Collect Subject Data
* Collect Blood Specimen Receives: Diagnostic Test: Freenome Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start6 Sep 2022
- Primary completion20 Dec 2023
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly-diagnosed CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freenome Holdings Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516927
- Sponsor's protocol ID
- The Sanderson Study/FRNM-006
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05516927
- Acronym / sponsor ID
- The Sanderson Study/FRNM-006
- Conditions
- Newly-diagnosed Cancers, Non-cancer Controls
- Keywords
- Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Freenome Holdings Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Group | – | Diagnostic Test: Freenome Test* Collect Subject Data * Collect Blood Specimen |
| Non-cancer Group | – | Diagnostic Test: Freenome Test* Collect Subject Data * Collect Blood Specimen |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults 30+ who have been newly diagnosed with cancer and treatment-naive * Adults 30+ without cancer
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freenome TestParticipants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. | Diagnostic test | Cancer Group, Non-cancer Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly-diagnosed Cancers and Non-cancer Controls, run by Freenome Holdings Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.