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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05254834
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

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.

Condition or disease Intervention/treatment
Cancer Diagnostic Test: Freenome Test

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Study Type : Observational
Estimated Enrollment : 5400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : December 31, 2024

Group/Cohort Intervention/treatment
Cancer Group
Collect Subject Data Collect Blood Specimen
Diagnostic Test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.

Non-cancer Group
Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status
Diagnostic Test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults 30+ who have been newly diagnosed (treatment-naive) with cancer and Adults 30+ without cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05254834


Contacts
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Contact: Tiffany Lui (650) 446-6630 frnm008@freenome.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
Freenome Holdings Inc.
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Responsible Party: Freenome Holdings Inc.
ClinicalTrials.gov Identifier: NCT05254834    
Other Study ID Numbers: The Vallania Study/FRNM-008
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Freenome Holdings Inc.:
Liquid Biopsy
Blood Test
Cancer Diagnostic
Genomics
Multiomics
Artificial Intelligence
Screening
Machine Learning
Freenome
Early Detection
Multicancer
Cancer