CancerNCT05254834
The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
An observational study of Cancer, run by Freenome Holdings Inc. at 68 sites in United States.
Trial summary
This protocol is a case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for 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
- Cancer
- What is being tested?
- Freenome Test
- How many people
- 7,435 participants
- Where
- 68 sitesUnited States
- Study dates
- 15 Feb 2022to 12 Jul 2025
- 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 (treatment-naive) with cancer and Adults 30+ without cancer
Who may be able to join
- Age at least 30 years
- Able and willing to provide blood samples per protocol
- Able to comprehend and willing to sign and date the informed consent documents
- Participants must meet one of the following:
- Diagnosed with a single primary cancer that has not yet been treated
- No evidence or treatment of any cancer for at least 5 years prior to enrollment
Who cannot join
- A medical condition which, in the opinion of the investigator, should preclude enrollment in the study
- Known to be pregnant
- Any therapy for cancer, including surgery, chemotherapy, 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 in the last 30 days
- Participated in or currently participating in another Freenome clinical study
- For the control cohort: 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 cohorts: 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
68 sites in 1 country.
68 sites in 1 country
United States68 sites
University of Michigan
Ann Arbor, Michigan, 48109
Morehouse School of Medicine
Atlanta, Georgia, 30310
Mercy Medical Center
Baltimore, Maryland, 21202
St. Charles Health System, Inc
Bend, Oregon, 97701
Billings Clinic
Billings, Montana, 59101
Central Alabama Research
Birmingham, Alabama, 35209
Alabama Oncology
Birmingham, Alabama, 35243
Central Care Cancer Center
Bolivar, Missouri, 65613
Massachusetts General Hospital
Boston, Massachusetts, 02114
RecioMed Clinical Research
Boynton Beach, Florida, 33472
Gabrail Cancer Center Research
Canton, Ohio, 44718
University of Chicago
Chicago, Illinois, 60637
John Muir Health
Concord, California, 94520
Carbon Health
Corona, California, 92883
Christus Spohn Shoreline Hospital
Corpus Christi, Texas, 78404
Objective Health Network
Dayton, Ohio, 45414
Doylestown Health
Doylestown, Pennsylvania, 18901
Cancer Center of Middle Georgia (QCCA)
Dublin, Georgia, 31021
Miller Bioconnect
El Cajon, California, 92021
Gastroenterology and Liver Institute
Escondido, California, 92025
ObjectiveHealth, Inc
Franklin, Tennessee, 37067
Women's Cancer Network
Fresno, California, 93710
Specicare
Gainesville, Georgia, 30501
Pennsylvania Cancer Specialists & Research Institute
Gettysburg, Pennsylvania, 17325
Altru Health System
Grand Forks, North Dakota, 58201
Oncology Consultants
Houston, Texas, 77030
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Logan Health Research
Kalispell, Montana, 59901
San Diego Clinical Trials
La Mesa, California, 91942
Saint Joseph Cancer Center
Lexington, Kentucky, 40509
Urology Alliance Clinical Research
Los Angeles, California, 90048
Centra Lynchburg Hematology Oncology
Lynchburg, Virginia, 24501
SSM Health-Dean Medical Group
Madison, Wisconsin, 53715
Mercy Cancer Center
Merced, California, 95340
University of Minnesota, School of Public Health, Environmental Health Sciences
Minneapolis, Minnesota, 55455
NYU
New York, New York, 10010
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360
Hightower Clinical Research
Oklahoma City, Oklahoma, 73102
Mid Florida Hematology & Oncology Center
Orange City, Florida, 32763
Emerald Coast OBGYN
Panama City, Florida, 32405
Ascension Sacred Heart
Pensacola, Florida, 32504
Thomas Jefferson University
Philadelphia, Pennsylvania, 19141
Pomona Valley Hospital Medical Center/Cancer Care Center
Pomona, California, 91767
NY Cancer & Blood Specialists
Port Jefferson Station, New York, 11776
Cancer Care Specialists Reno
Reno, Nevada, 93710
Objective Health Network
Richmond, Virginia, 23236
Ascension Providence Rochester Hospital
Rochester Hills, Michigan, 48309
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
Northwest Oncology & Hematology
Rolling Meadows, Illinois, 60008
Covenant HealthCare
Saginaw, Michigan, 48604
St. Mary's Medical Center
San Francisco, California, 94117
Dominican Hospital Dignity Health
Santa Cruz, California, 94520
Donald Guthrie Foundation
Sayre, Pennsylvania, 18840
Honor Health
Scottsdale, Arizona, 85258
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Objective Health Network (Digestive Research Alliance of Michiana, LLC)
South Bend, Indiana, 46635
Highlands Oncology Group
Springdale, Arkansas, 72762
Stockton Hematology Oncology
Stockton, California, 95204
Northwest Medical Specialties (QCCA)
Tacoma, Washington, 98405
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
Christus Trinity Mother Frances Health System
Tyler, Texas, 75702
Inspira Medical Center Vineland
Vineland, New Jersey, 08360
White Plains Hospital
White Plains, New York, 10601
Ascension Via Christi Hospital, Wichita
Wichita, Kansas, 67214
USDH Clinical Research
Wyomissing, Pennsylvania, 19160
Cancer Care Associates of York (QCCA)
York, Pennsylvania, 17403
About this study
This protocol is a case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for multiple cancers.
- Conditions
- Cancer
- Being tested
- Freenome Test
- Keywords
- Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning, Freenome, Early Detection, Multicancer, Cancer
- Medical subject headings
- Neoplasms
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 One Year Follow Up On Cancer Status 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 posted24 Feb 2022
- Study start15 Feb 2022
- Primary completion24 Jul 2024
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 7,435 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
- NCT05254834
- Sponsor's protocol ID
- The Vallania Study/FRNM-008
- Status last verified
- Aug 2025
- First submitted
- 15 Feb 2022
- Last updated
- 22 Aug 2025
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
- ClinicalTrials.gov ID
- NCT05254834
- Acronym / sponsor ID
- The Vallania Study/FRNM-008
- Conditions
- Cancer
- Keywords
- Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,435 participants (actual)
- Lead sponsor
- Freenome Holdings Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 24 Feb 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 case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for multiple cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Group | – | Diagnostic Test: Freenome TestCollect Subject Data Collect Blood Specimen |
| Non-cancer Group | – | Diagnostic Test: Freenome TestCollect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status |
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 (treatment-naive) with cancer and Adults 30+ without cancer
Key inclusion criteria (6 listed)
- Age at least 30 years
- Able and willing to provide blood samples per protocol
- Able to comprehend and willing to sign and date the informed consent documents
- Participants must meet one of the following:
Key exclusion criteria (7 listed)
- A medical condition which, in the opinion of the investigator, should preclude enrollment in the study
- Known to be pregnant
- Any therapy for cancer, including surgery, chemotherapy, 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 in the last 30 days
- Participated in or currently participating in another Freenome clinical study
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 22 Aug 2025.
- 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.
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Freenome Holdings Inc. at 68 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 6 inclusion and 7 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 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 22 Aug 2025.