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Completed

NCT Number: NCT05254834

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.

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Key information

Conditions

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alabama Oncology, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freenome Test

Diagnostic Test

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.

Primary outcomes

  1. Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Freenome Holdings Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 24, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.