Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-30 @ 10:32 AM
Study NCT ID:
NCT05254834
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Sponsor:
Organization:
Raw JSON
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'2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Liquid Biopsy', 'Blood Test', 'Cancer Diagnostic', 'Genomics', 'Multiomics', 'Artificial Intelligence', 'Screening', 'Machine Learning', 'Freenome', 'Early Detection', 'Multicancer', 'Cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults 30+ who have been newly diagnosed (treatment-naive) with cancer and Adults 30+ without cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age at least 30 years\n* Able and willing to provide blood samples per protocol\n* Able to comprehend and willing to sign and date the informed consent documents\n* Participants must meet one of the following:\n\n * Diagnosed with a single primary cancer that has not yet been treated\n * No evidence or treatment of any cancer for at least 5 years prior to enrollment\n\nKey Exclusion Criteria:\n\n* A medical condition which, in the opinion of the investigator, should preclude enrollment in the study\n* Known to be pregnant\n* Any therapy for cancer, including surgery, chemotherapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment\n* Participated or currently participating in a clinical research study in which an experimental medication has been administered in the last 30 days\n* Participated in or currently participating in another Freenome clinical study\n* 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\n* 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'}, 'identificationModule': {'nctId': 'NCT05254834', 'briefTitle': 'The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening', 'organization': {'class': 'INDUSTRY', 'fullName': 'Freenome Holdings Inc.'}, 'officialTitle': 'The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening', 'orgStudyIdInfo': {'id': 'The Vallania Study/FRNM-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Group', 'description': 'Collect Subject Data Collect Blood Specimen', 'interventionNames': ['Diagnostic Test: Freenome Test']}, {'label': 'Non-cancer Group', 'description': 'Collect Subject Data Collect Blood Specimen One Year Follow Up On Cancer Status', 'interventionNames': ['Diagnostic Test: Freenome Test']}], 'interventions': [{'name': 'Freenome Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.', 'armGroupLabels': ['Cancer Group', 'Non-cancer Group']}]}, 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