The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Trial ID: NCT05254834
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-02-15
Completion date: 2025-07-12
Sponsor: Freenome Holdings Inc.
Conditions: Cancer
Interventions: Freenome Test
Locations: Central Alabama Research; Alabama Oncology; Honor Health; Highlands Oncology Group; John Muir Health; Carbon Health; Miller Bioconnect; Gastroenterology and Liver Institute; Women's Cancer Network; San Diego Clinical Trials; Urology Alliance Clinical Research; Mercy Cancer Center; Pomona Valley Hospital Medical Center/Cancer Care Center; St. Mary's Medical Center; Dominican Hospital Dignity Health; Stockton Hematology Oncology; Torrance Memorial Physician Network - Cancer Care; Eastern CT Hematology and Oncology Associates; RecioMed Clinical Research; Mid Florida Hematology & Oncology Center; Emerald Coast OBGYN; Ascension Sacred Heart; Morehouse School of Medicine; Cancer Center of Middle Georgia (QCCA); Specicare; University of Chicago; Northwest Oncology & Hematology; Objective Health Network (Digestive Research Alliance of Michiana, LLC); Ascension Via Christi Hospital, Wichita; Saint Joseph Cancer Center; Louisiana State University Health Sciences Center; Louisiana Research Center, LLC; Mercy Medical Center; Massachusetts General Hospital; University of Michigan; Ascension Providence Rochester Hospital; Covenant HealthCare; University of Minnesota, School of Public Health, Environmental Health Sciences; Central Care Cancer Center; Billings Clinic; Logan Health Research; Cancer Care Specialists Reno; Inspira Medical Center Vineland; NYU; NY Cancer & Blood Specialists; White Plains Hospital; Altru Health System; Gabrail Cancer Center Research; Objective Health Network; Hightower Clinical Research; St. Charles Health System, Inc; Doylestown Health; Pennsylvania Cancer Specialists & Research Institute; Thomas Jefferson University; Donald Guthrie Foundation; USDH Clinical Research; Cancer Care Associates of York (QCCA); Carolina Blood and Cancer Care Associates; Avera Cancer Institute; ObjectiveHealth, Inc; Christus Spohn Shoreline Hospital; Oncology Consultants; The University of Texas M.D. Anderson Cancer Center; Christus Trinity Mother Frances Health System; Centra Lynchburg Hematology Oncology; Objective Health Network; Northwest Medical Specialties (QCCA); SSM Health-Dean Medical Group
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 7435
Age range: 30 Years - None
Sex: ALL

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

Outcomes:
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants