Cancer Clinical Trial
Official title:
The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
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.
| Status | Recruiting |
| Enrollment | 5400 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | June 28, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 30 Years and older |
| Eligibility | Key Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Morehouse School of Medicine | Atlanta | Georgia |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | St. Charles Health System, Inc | Bend | Oregon |
| United States | Billings Clinic | Billings | Montana |
| United States | Alabama Oncology | Birmingham | Alabama |
| United States | Central Alabama Research | Birmingham | Alabama |
| United States | Central Care Cancer Center | Bolivar | Missouri |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | RecioMed Clinical Research | Boynton Beach | Florida |
| United States | Gabrail Cancer Center Research | Canton | Ohio |
| United States | University of Chicago | Chicago | Illinois |
| United States | John Muir Health | Concord | California |
| United States | Carbon Health | Corona | California |
| United States | Christus Spohn Shoreline Hospital | Corpus Christi | Texas |
| United States | Objective Health Network | Dayton | Ohio |
| United States | Doylestown Health | Doylestown | Pennsylvania |
| United States | Cancer Center of Middle Georgia (QCCA) | Dublin | Georgia |
| United States | Miller Bioconnect | El Cajon | California |
| United States | Gastroenterology and Liver Institute | Escondido | California |
| United States | ObjectiveHealth, Inc | Franklin | Tennessee |
| United States | Women's Cancer Network | Fresno | California |
| United States | Specicare | Gainesville | Georgia |
| United States | Pennsylvania Cancer Specialists & Research Institute | Gettysburg | Pennsylvania |
| United States | Altru Health System | Grand Forks | North Dakota |
| United States | Oncology Consultants | Houston | Texas |
| United States | The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
| United States | Logan Health Research | Kalispell | Montana |
| United States | San Diego Clinical Trials | La Mesa | California |
| United States | Saint Joseph Cancer Center | Lexington | Kentucky |
| United States | Urology Alliance Clinical Research | Los Angeles | California |
| United States | Centra Lynchburg Hematology Oncology | Lynchburg | Virginia |
| United States | SSM Health-Dean Medical Group | Madison | Wisconsin |
| United States | Mercy UC Davis Cancer Center (CommonSpirit) | Merced | California |
| United States | University of Minnesota, School of Public Health, Environmental Health Sciences | Minneapolis | Minnesota |
| United States | NYU | New York | New York |
| United States | Eastern CT Hematology and Oncology Associates | Norwich | Connecticut |
| United States | Hightower Clinical Research | Oklahoma City | Oklahoma |
| United States | Mid Florida Hematology & Oncology Center | Orange City | Florida |
| United States | Emerald Coast OBGYN | Panama City | Florida |
| United States | Ascension Sacred Heart | Pensacola | Florida |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Pomona Valley Hospital Medical Center/Cancer Care Center | Pomona | California |
| United States | NY Cancer & Blood Specialists | Port Jefferson Station | New York |
| United States | Cancer Care Specialists Reno | Reno | Nevada |
| United States | Objective Health Network | Richmond | Virginia |
| United States | Ascension Providence Rochester Hospital | Rochester Hills | Michigan |
| United States | Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina |
| United States | Northwest Oncology & Hematology | Rolling Meadows | Illinois |
| United States | Covenant HealthCare | Saginaw | Michigan |
| United States | St. Mary's Medical Center | San Francisco | California |
| United States | Dominican Hospital Dignity Health | Santa Cruz | California |
| United States | Donald Guthrie Foundation | Sayre | Pennsylvania |
| United States | Honor Health | Scottsdale | Arizona |
| United States | Louisiana Research Center, LLC | Shreveport | Louisiana |
| United States | Louisiana State University Health Sciences Center | Shreveport | Louisiana |
| United States | Avera Cancer Institute | Sioux Falls | South Dakota |
| United States | Highlands Oncology Group | Springdale | Arkansas |
| United States | Stockton Hematology Oncology | Stockton | California |
| United States | Northwest Medical Specialties (QCCA) | Tacoma | Washington |
| United States | Torrance Memorial Physician Network - Cancer Care | Torrance | California |
| United States | Christus Trinity Mother Frances Health System | Tyler | Texas |
| United States | Inspira Medical Center Vineland | Vineland | New Jersey |
| United States | White Plains Hospital | White Plains | New York |
| United States | Ascension Via Christi Hospital, Wichita | Wichita | Kansas |
| United States | USDH Clinical Research | Wyomissing | Pennsylvania |
| United States | Cancer Care Associates of York (QCCA) | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Freenome Holdings Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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