Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-22 @ 4:17 PM
Study NCT ID:
NCT06586203
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000096442', 'term': 'Genetic Risk Score'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A) A pragmatic trial designed to evaluate the effectiveness of GENOCORDIA PRS testing in real-life routine practice conditions.\n\nB) Randomization of participants into informed and uninformed populations of the Polygenic risk score test result.\n\nC) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result after 12 months if positive results.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2714}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2028-08-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Microvascular and macrovascular endpoints', 'timeFrame': '18 months', 'description': 'Macrovascular outcome comprises nonfatal stroke, nonfatal acute coronary syndrome and death from any cardiovascular cause. Microvascular endpoint comprises new or worsening nephropathy defined as the development of macroalbuminuria, doubling of serum creatinine, requirement for renal replacement therapy or death from renal disease.'}], 'primaryOutcomes': [{'measure': 'Composite endpoint consisting of HbA1c, SBP, albuminuria or GFR', 'timeFrame': 'Visit to visit up to 18 months', 'description': 'Change of HbA1c, or SBP or albuminuria stage or eGFR decline. Percent of participants at therapeutic targets.'}], 'secondaryOutcomes': [{'measure': 'Medications for blood pressure, blood glucose and lipids', 'timeFrame': 'Visit to vist up to 18 months', 'description': 'change of class or dosage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Cardiorenal complications', 'Polygenic risk scores', 'Therapeutic targets', 'Precision Medicine', 'Prevention'], 'conditions': ['Diabetes Mellitus, Type 2', 'Cardiovascular Diseases', 'Diabetic Nephropathy Type 2']}, 'referencesModule': {'references': [{'pmid': '34226943', 'type': 'BACKGROUND', 'citation': 'Tremblay J, Haloui M, Attaoua R, Tahir R, Hishmih C, Harvey F, Marois-Blanchet FC, Long C, Simon P, Santucci L, Hizel C, Chalmers J, Marre M, Harrap S, Cifkova R, Krajcoviechova A, Matthews DR, Williams B, Poulter N, Zoungas S, Colagiuri S, Mancia G, Grobbee DE, Rodgers A, Liu L, Agbessi M, Bruat V, Fave MJ, Harwood MP, Awadalla P, Woodward M, Hussin JG, Hamet P. Polygenic risk scores predict diabetes complications and their response to intensive blood pressure and glucose control. Diabetologia. 2021 Sep;64(9):2012-2025. doi: 10.1007/s00125-021-05491-7. Epub 2021 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these complications achieve over an 18 months period, recommended therapeutic targets.\n\nThis will be demonstrated as a significant improvement in a composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR), or glomerular filtration rate (GFR) lowering.\n\nResearchers will compare the recommended therapeutic targets of uninformed and informed patients to see if the knowledge of the risk by the patients and their treating physicians improves achievement of these targets.\n\nParticipants will:\n\nHave a saliva sampling to determine the genetic risk. Visit the clinic once every 3 months for checkups and tests Answer two questionnaires on quality of life.', 'detailedDescription': 'Type 2 diabetes (T2D) increases the risk of developing serious cardiovascular and kidney complications that represent a major burden for both patients and our healthcare system. Currently, patients with T2D are treated according to guidelines, with varied results in terms of systolic blood pressure (SBP), blood glucose (HbA1c), urine albumin-creatinine ratio (UACR) and glomerular filtration rate (GFR) target achievement.\n\nOPTITHERA has developed the first genomic test to predict the risk of cardiorenal complications that will allow early and personalized treatment of patients with T2D who are at high risk using Polygenic risk score.\n\nIt is proposed that knowledge of the risk of developing complications of diabetes will have a positive effect on the care pathway of diabetic patients: the patient will be able to actively participate in their care and their doctor will be able to adapt his treatment to his personal risk, especially if his patient is at high risk of complications.\n\nObjective: To provide Real World Evidence (RWE) on the impact of the result of a PRS prediction test on the risk of complications of T2D, so that patients at high risk of complications achieve, over an 18-month period, recommended targets for systolic blood pressure (≤130 mmHg) or HbA1c (\\<7.0%), or decreased albuminuria grade, GFR decline, while avoiding severe hypoglycemia and falls.\n\nThis will be demonstrated as a significant improvement in composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR).\n\nMethodology: Multicenter Study: A) Pragmatic trial designed to evaluate the effectiveness of GENOCORDIA PRS testing in real-life routine practice conditions.\n\nB) Randomization of participants into informed and uninformed populations of the PRS test result. C) Adaptive trial for the treatment of subjects initially uninformed of their PRS test result.\n\nEstimated number of participants: 2714 participants randomized into two groups. Estimated study enrollment duration= 9 months. Estimated total study duration = 36 months. 18 months follow-up (7 visits).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with T2D of both sexes regardless of ethnicity, level of diabetes control and presence of complications.\n* Able to visit the study site 7 times\n* Able and willing to provide informed consent to the clinical and PRS parts of the study.\n\nExclusion Criteria:\n\n* Any condition that may impact participation in a real-world study according to the treating physician.\n* People with a high frailty index as no benefit of therapeutic intensification has been demonstrated in these diabetic patients.\n* People who refuse to be informed of their cardiorenal risk score.'}, 'identificationModule': {'nctId': 'NCT06586203', 'acronym': 'GENOCORDIA', 'briefTitle': 'Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optithera'}, 'officialTitle': 'New GENOmic Predictor for COmplications Risk in Type 2 DIAbetes', 'orgStudyIdInfo': {'id': 'OPT0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Informed', 'description': 'Intervention group tested and informed of the Polygenic risk score test result at the start of the study', 'interventionNames': ['Device: Polygenic Risk Score']}, {'type': 'NO_INTERVENTION', 'label': 'Not initially informed', 'description': 'Control group: tested but not informed of the Polygenic Risk Score test result at the start of the study.'}], 'interventions': [{'name': 'Polygenic Risk Score', 'type': 'DEVICE', 'otherNames': ['Risk Prediction'], 'description': "The Polygenic Risk Score (PRS) is a Class II software as a medical device (SaMD) that estimates a person's level of risk of developing a disease or associated complications before clinical signs appear. The device uses the genomic profile of the person in combination with some clinical data (i.e., age, sex, age of onset of diabetes) to compute this risk. This device further provides recommendations for personalized management of T2D for patients based on their risk score.", 'armGroupLabels': ['Informed']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie-Renée Guertin, Il, CRA', 'role': 'CONTACT', 'email': 'marie.renee.guertin.chum@ssss.gouv.qc.ca', 'phone': '1-514-249-4209'}, {'name': 'Pavel Hamet, MD, PhD', 'role': 'CONTACT', 'phone': '1-514-862-2378'}], 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3S 1Z5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rose-Lyne Allouch, MD', 'role': 'CONTACT', 'email': 'rallouch@cdllabs.com', 'phone': '1-514-344-8022', 'phoneExt': '275'}], 'facility': 'ELNA Medical', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Marie-Renée Guertin, il,cra', 'role': 'CONTACT', 'email': 'marie-renee.guertin.chum@ssss.gouv.qc.ca', 'phone': '514-249-4209'}, {'name': 'Johanne Tremblay, PhD', 'role': 'CONTACT', 'email': 'johanne@optithera.onmicrosoft.com', 'phone': '514-890-8247'}], 'overallOfficials': [{'name': 'Pavel Hamet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUM'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Six months after study publication.', 'ipdSharing': 'YES', 'description': 'De-identified patient data at the end of the study including risk strata.', 'accessCriteria': 'Contact the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optithera', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genome Quebec', 'class': 'OTHER'}, {'name': 'Genome Canada', 'class': 'OTHER'}, {'name': 'ELNA Medical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}