The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
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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 |
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Recruitment Status :
Recruiting
First Posted : February 24, 2022
Last Update Posted : March 17, 2023
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Sponsor:
Freenome Holdings Inc.
Information provided by (Responsible Party):
Freenome Holdings Inc.
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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 |
| 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 : | February 28, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cancer Group
Collect Subject Data Collect Blood Specimen
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Diagnostic Test: Freenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. |
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Non-cancer Group
Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status
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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 :
- 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
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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
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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
| Contact: Joye Choy | (650) 446-6630 | frnm008@freenome.com |
Locations
Show 60 study locations
Sponsors and Collaborators
Freenome Holdings Inc.
| 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: | March 17, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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.:
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Liquid Biopsy Blood Test Cancer Diagnostic Genomics Multiomics Artificial Intelligence |
Screening Machine Learning Freenome Early Detection Multicancer Cancer |