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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 : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

Tracking Information
First Submitted Date February 15, 2022
First Posted Date February 24, 2022
Last Update Posted Date January 17, 2023
Actual Study Start Date February 15, 2022
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2022)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Official Title The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test
Sampling Method Non-Probability Sample
Study Population Adults 30+ who have been newly diagnosed (treatment-naive) with cancer and Adults 30+ without cancer
Condition Cancer
Intervention Diagnostic Test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
Study Groups/Cohorts
  • Cancer Group
    Collect Subject Data Collect Blood Specimen
    Intervention: Diagnostic Test: Freenome Test
  • Non-cancer Group
    Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status
    Intervention: Diagnostic Test: Freenome Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 15, 2022)		 5400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date February 28, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Joye Choy (650) 446-6630 frnm008@freenome.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05254834
Other Study ID Numbers The Vallania Study/FRNM-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Freenome Holdings Inc.
Original Responsible Party Same as current
Current Study Sponsor Freenome Holdings Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Freenome Holdings Inc.
Verification Date January 2023