The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
- Conditions
- Cancer
- Interventions
- Diagnostic Test: Freenome Test
- Registration Number
- NCT05254834
- Lead Sponsor
- Freenome Holdings Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5400
-
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
Key
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cancer Group Freenome Test Collect Subject Data Collect Blood Specimen Non-cancer Group Freenome Test Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status
- Primary Outcome Measures
Name Time Method Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (67)
The University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Oncology Consultants
🇺🇸Houston, Texas, United States
Objective Health Network (Digestive Research Alliance of Michiana, LLC)
🇺🇸South Bend, Indiana, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
John Muir Health
🇺🇸Concord, California, United States
Gastroenterology and Liver Institute
🇺🇸Escondido, California, United States
St. Mary's Medical Center
🇺🇸San Francisco, California, United States
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
Mercy UC Davis Cancer Center (CommonSpirit)
🇺🇸Merced, California, United States
Emerald Coast OBGYN
🇺🇸Panama City, Florida, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Carbon Health
🇺🇸Corona, California, United States
Miller Bioconnect
🇺🇸El Cajon, California, United States
Women's Cancer Network
🇺🇸Fresno, California, United States
Pomona Valley Hospital Medical Center/Cancer Care Center
🇺🇸Pomona, California, United States
RecioMed Clinical Research
🇺🇸Boynton Beach, Florida, United States
Mid Florida Hematology & Oncology Center
🇺🇸Orange City, Florida, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Urology Alliance Clinical Research
🇺🇸Los Angeles, California, United States
Dominican Hospital Dignity Health
🇺🇸Santa Cruz, California, United States
Stockton Hematology Oncology
🇺🇸Stockton, California, United States
Torrance Memorial Physician Network - Cancer Care
🇺🇸Torrance, California, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
Cancer Center of Middle Georgia (QCCA)
🇺🇸Dublin, Georgia, United States
Specicare
🇺🇸Gainesville, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Northwest Oncology & Hematology
🇺🇸Rolling Meadows, Illinois, United States
Ascension Via Christi Hospital, Wichita
🇺🇸Wichita, Kansas, United States
Saint Joseph Cancer Center
🇺🇸Lexington, Kentucky, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Ascension Providence Rochester Hospital
🇺🇸Rochester Hills, Michigan, United States
Covenant HealthCare
🇺🇸Saginaw, Michigan, United States
University of Minnesota, School of Public Health, Environmental Health Sciences
🇺🇸Minneapolis, Minnesota, United States
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Logan Health Research
🇺🇸Kalispell, Montana, United States
Cancer Care Specialists Reno
🇺🇸Reno, Nevada, United States
Inspira Medical Center Vineland
🇺🇸Vineland, New Jersey, United States
NYU
🇺🇸New York, New York, United States
NY Cancer & Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
Altru Health System
🇺🇸Grand Forks, North Dakota, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Objective Health Network
🇺🇸Richmond, Virginia, United States
Hightower Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
St. Charles Health System, Inc
🇺🇸Bend, Oregon, United States
Doylestown Health
🇺🇸Doylestown, Pennsylvania, United States
Pennsylvania Cancer Specialists & Research Institute
🇺🇸Gettysburg, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Donald Guthrie Foundation
🇺🇸Sayre, Pennsylvania, United States
USDH Clinical Research
🇺🇸Wyomissing, Pennsylvania, United States
Cancer Care Associates of York (QCCA)
🇺🇸York, Pennsylvania, United States
Carolina Blood and Cancer Care Associates
🇺🇸Rock Hill, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
ObjectiveHealth, Inc
🇺🇸Franklin, Tennessee, United States
Christus Spohn Shoreline Hospital
🇺🇸Corpus Christi, Texas, United States
Christus Trinity Mother Frances Health System
🇺🇸Tyler, Texas, United States
Centra Lynchburg Hematology Oncology
🇺🇸Lynchburg, Virginia, United States
Northwest Medical Specialties (QCCA)
🇺🇸Tacoma, Washington, United States
SSM Health-Dean Medical Group
🇺🇸Madison, Wisconsin, United States