Status:
COMPLETED
The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Lead Sponsor:
Freenome Holdings Inc.
Conditions:
Cancer
Eligibility:
All Genders
30+ years
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
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 12 2025
Estimated Enrollment :
7435 Patients enrolled
Trial Details
Trial ID
NCT05254834
Start Date
February 15 2022
End Date
July 12 2025
Last Update
August 22 2025
Active Locations (68)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Alabama Oncology
Birmingham, Alabama, United States, 35243
3
Honor Health
Scottsdale, Arizona, United States, 85258
4
Highlands Oncology Group
Springdale, Arkansas, United States, 72762