The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Freenome

Status

Completed

Conditions

Cancer

Treatments

Diagnostic Test: Freenome Test

Study type

Observational

Funder types

Industry

Identifiers

NCT05254834

The Vallania Study/FRNM-008

Details and patient eligibility

About

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.

Enrollment

7,435 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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