The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
1 other identifier
observational
7,435
1 country
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Typical duration for all trials
68 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
February 15, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2025
CompletedAugust 22, 2025
August 1, 2025
2.4 years
February 15, 2022
August 21, 2025
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 One Year Follow Up On Cancer Status
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 (treatment-naive) with cancer and Adults 30+ without cancer
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Central Alabama Research
Birmingham, Alabama, 35209, United States
Alabama Oncology
Birmingham, Alabama, 35243, United States
Honor Health
Scottsdale, Arizona, 85258, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
John Muir Health
Concord, California, 94520, United States
Carbon Health
Corona, California, 92883, United States
Miller Bioconnect
El Cajon, California, 92021, United States
Gastroenterology and Liver Institute
Escondido, California, 92025, United States
Women's Cancer Network
Fresno, California, 93710, United States
San Diego Clinical Trials
La Mesa, California, 91942, United States
Urology Alliance Clinical Research
Los Angeles, California, 90048, United States
Mercy Cancer Center
Merced, California, 95340, United States
Pomona Valley Hospital Medical Center/Cancer Care Center
Pomona, California, 91767, United States
St. Mary's Medical Center
San Francisco, California, 94117, United States
Dominican Hospital Dignity Health
Santa Cruz, California, 94520, United States
Stockton Hematology Oncology
Stockton, California, 95204, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
RecioMed Clinical Research
Boynton Beach, Florida, 33472, United States
Mid Florida Hematology & Oncology Center
Orange City, Florida, 32763, United States
Emerald Coast OBGYN
Panama City, Florida, 32405, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Cancer Center of Middle Georgia (QCCA)
Dublin, Georgia, 31021, United States
Specicare
Gainesville, Georgia, 30501, United States
University of Chicago
Chicago, Illinois, 60637, United States
Northwest Oncology & Hematology
Rolling Meadows, Illinois, 60008, United States
Objective Health Network (Digestive Research Alliance of Michiana, LLC)
South Bend, Indiana, 46635, United States
Ascension Via Christi Hospital, Wichita
Wichita, Kansas, 67214, United States
Saint Joseph Cancer Center
Lexington, Kentucky, 40509, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Ascension Providence Rochester Hospital
Rochester Hills, Michigan, 48309, United States
Covenant HealthCare
Saginaw, Michigan, 48604, United States
University of Minnesota, School of Public Health, Environmental Health Sciences
Minneapolis, Minnesota, 55455, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Billings Clinic
Billings, Montana, 59101, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Cancer Care Specialists Reno
Reno, Nevada, 93710, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
NYU
New York, New York, 10010, United States
NY Cancer & Blood Specialists
Port Jefferson Station, New York, 11776, United States
White Plains Hospital
White Plains, New York, 10601, United States
Altru Health System
Grand Forks, North Dakota, 58201, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Objective Health Network
Dayton, Ohio, 45414, United States
Hightower Clinical Research
Oklahoma City, Oklahoma, 73102, United States
St. Charles Health System, Inc
Bend, Oregon, 97701, United States
Doylestown Health
Doylestown, Pennsylvania, 18901, United States
Pennsylvania Cancer Specialists & Research Institute
Gettysburg, Pennsylvania, 17325, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19141, United States
Donald Guthrie Foundation
Sayre, Pennsylvania, 18840, United States
USDH Clinical Research
Wyomissing, Pennsylvania, 19160, United States
Cancer Care Associates of York (QCCA)
York, Pennsylvania, 17403, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
ObjectiveHealth, Inc
Franklin, Tennessee, 37067, United States
Christus Spohn Shoreline Hospital
Corpus Christi, Texas, 78404, United States
Oncology Consultants
Houston, Texas, 77030, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, 75702, United States
Centra Lynchburg Hematology Oncology
Lynchburg, Virginia, 24501, United States
Objective Health Network
Richmond, Virginia, 23236, United States
Northwest Medical Specialties (QCCA)
Tacoma, Washington, 98405, United States
SSM Health-Dean Medical Group
Madison, Wisconsin, 53715, United States
Biospecimen
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
February 24, 2022
Study Start
February 15, 2022
Primary Completion
July 24, 2024
Study Completion
July 12, 2025
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share