Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:26 AM
Study NCT ID:
NCT07462234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous N-of-1 Computational Feasibility Study of a Whole Genome Sequence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Deterministic In Silico Metabolic Flux Simulation', 'timeFrame': '3 months', 'description': 'Assesses whether secondary 30x Whole Genome Sequencing (WGS) data can be successfully ingested and processed by a deterministic computational framework that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. Feasibility is defined by the ability to run simulations without system failure, data corruption, or computational instability. This outcome evaluates computational performance only and does not assess clinical endpoints.'}], 'secondaryOutcomes': [{'measure': 'Generation of a Jacobian Sensitivity Atlas', 'timeFrame': '3 months', 'description': 'Evaluates whether the simulation engine can successfully generate a differentiable sensitivity atlas that identifies potential enzymatic or transport constraints based solely on static genomic inputs. This outcome assesses algorithmic output quality and computational stability, not clinical or diagnostic interpretation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Whole Genome Sequencing', 'N-of-1', 'Computational Modeling', 'Metabolic Pathways', 'Flux Balance Analysis', 'Bioenergetics', 'Genomic Simulation', 'Deterministic Modeling', 'Secondary Data Analysis'], 'conditions': ['Computational Modeling of Individual Metabolic Pathways']}, 'descriptionModule': {'briefSummary': 'This is an observational, computational N-of-1 study that uses previously collected Whole Genome Sequencing (WGS) data from a single adult participant to evaluate the feasibility of a deterministic bioenergetic simulation model. The study does not involve clinical interventions, treatments, or prospective specimen collection. All analyses are performed on existing genomic data in a secure computational environment.\n\nThe purpose of this study is to determine whether a physics-based metabolic model can successfully integrate individual genomic constraints to generate personalized, hypothesis-driven insights about metabolic pathways. The study focuses on model feasibility and computational performance, not clinical outcomes. No medications, diets, or behavioral interventions are administered or evaluated.', 'detailedDescription': 'This protocol (B-2026-N1) describes a continuous, observational N-of-1 computational feasibility study conducted by Bioactify LLC and What Ifs Tech Inc. The study uses secondary, commercially obtained 30x Whole Genome Sequencing (WGS) data from a single adult participant. No new data are collected for research purposes, and no clinical interventions are performed.\n\nThe primary objective is to assess the feasibility of integrating static genomic constraints into a deterministic simulation engine that incorporates Flux Balance Analysis (FBA) and dynamic physiologically based modeling. The computational framework is designed to explore how individual genetic variants may influence metabolic pathway behavior. All analyses occur within an isolated cloud environment using pre-existing data.\n\nThis study is observational and exploratory. It does not evaluate the safety, efficacy, or clinical utility of any treatment, diet, medication, or device. The research aims to generate methodological insights about individualized computational modeling and hypothesis generation.\n\nThis study received an Exempt Research Determination from Pearl IRB (Protocol ID: 2026-0119) under 45 CFR 46.104(d)(4), as it involves only secondary use of existing data with no interaction or intervention with human subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Single adult participant providing previously collected Whole Genome Sequencing (WGS) data for observational, computational analysis. No recruitment or enrollment of additional participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female participant, age 45\n\n * Possesses previously collected 30x Whole Genome Sequencing (WGS) data\n * Able to provide self-reported phenotypic and lifestyle information as needed for computational analysis\n * Willing to participate in a self-directed, observational N-of-1 study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07462234', 'acronym': 'B2026N1', 'briefTitle': 'Continuous N-of-1 Computational Feasibility Study of a Whole Genome Sequence', 'organization': {'class': 'OTHER', 'fullName': 'Bioactify LLC'}, 'officialTitle': 'Automated Hypothesis Generation Via Deterministic Bioenergetic Simulation of a Whole Genome Sequence: A Continuous N-of-1 Computational Feasibility Study', 'orgStudyIdInfo': {'id': 'B-2026-N1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Participant', 'description': 'This cohort includes the single adult participant whose previously collected Whole Genome Sequencing (WGS) data will be used for computational analysis. No interventions, treatments, or clinical procedures are performed. All analyses are observational and based solely on secondary data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12590', 'city': 'Wappingers Falls', 'state': 'New York', 'country': 'United States', 'facility': 'Bioactify LLC', 'geoPoint': {'lat': 41.59648, 'lon': -73.91097}}], 'overallOfficials': [{'name': 'Esther Cashbaugh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bioactify LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the study includes a single participant and uses previously collected Whole Genome Sequencing (WGS) data that cannot be de-identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioactify LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}