Clinical trial NCT05254834: The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Official title: The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: Liquid Biopsy
Blood Test
Cancer Diagnostic
Genomics
Multiomics
Artificial Intelligence
Screening
Machine Learning
Freenome
Early Detection
Multicancer
Cancer
Lead sponsor: Freenome Holdings Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 5400
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 30+ who have been newly diagnosed (treatment-naive) with cancer and Adults 30+ without cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Concord
country: United States
facility: John Muir Health
state: California
city: Corona
country: United States
facility: Carbon Health
state: California
city: El Cajon
country: United States
facility: Miller Bioconnect
state: California
city: Escondido
country: United States
facility: Gastroenterology and Liver Institute
state: California
city: Fresno
country: United States
facility: Women's Cancer Network
state: California
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Urology Alliance Clinical Research
state: California
city: Merced
country: United States
facility: Mercy UC Davis Cancer Center (CommonSpirit)
state: California
city: Pomona
country: United States
facility: Pomona Valley Hospital Medical Center/Cancer Care Center
state: California
city: San Francisco
country: United States
facility: St. Mary's Medical Center
state: California
city: Santa Cruz
country: United States
facility: Dominican Hospital Dignity Health
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network - Cancer Care
state: California
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Boynton Beach
country: United States
facility: RecioMed Clinical Research
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology & Oncology Center
state: Florida
city: Panama City
country: United States
facility: Emerald Coast OBGYN
state: Florida
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Dublin
country: United States
facility: Cancer Center of Middle Georgia (QCCA)
state: Georgia
city: Gainesville
country: United States
facility: Specicare
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Oncology & Hematology
state: Illinois
city: South Bend
country: United States
facility: Objective Health Network (Digestive Research Alliance of Michiana, LLC)
state: Indiana
city: Wichita
country: United States
facility: Ascension Via Christi Hospital, Wichita
state: Kansas
city: Lexington
country: United States
facility: Saint Joseph Cancer Center
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester Hills
country: United States
facility: Ascension Providence Rochester Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant HealthCare
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota, School of Public Health, Environmental Health Sciences
state: Minnesota
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Reno
country: United States
facility: Cancer Care Specialists Reno
state: Nevada
city: Vineland
country: United States
facility: Inspira Medical Center Vineland
state: New Jersey
city: New York
country: United States
facility: NYU
state: New York
city: Port Jefferson Station
country: United States
facility: NY Cancer & Blood Specialists
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Dayton
country: United States
facility: Objective Health Network
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical Research
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Health System, Inc
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Health
state: Pennsylvania
city: Gettysburg
country: United States
facility: Pennsylvania Cancer Specialists & Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation
state: Pennsylvania
city: Wyomissing
country: United States
facility: USDH Clinical Research
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York (QCCA)
state: Pennsylvania
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Franklin
country: United States
facility: ObjectiveHealth, Inc
state: Tennessee
city: Corpus Christi
country: United States
facility: Christus Spohn Shoreline Hospital
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Lynchburg
country: United States
facility: Centra Lynchburg Hematology Oncology
state: Virginia
city: Richmond
country: United States
facility: Objective Health Network
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties (QCCA)
state: Washington
city: Madison
country: United States
facility: SSM Health-Dean Medical Group
state: Wisconsin
Study officials:
References: