Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-04 @ 4:07 PM
Study NCT ID:
NCT02095769
Status:
UNKNOWN
Last Update Posted:
2015-02-24
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280000}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Meaningful Change in Drug Regimen', 'timeFrame': '90 days', 'description': "The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:\n\n1. A genotype known to affect a drug the subject is taking is identified, and\n2. The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation."}], 'secondaryOutcomes': [{'measure': 'Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results', 'timeFrame': '90 days'}, {'measure': 'Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results', 'timeFrame': '90 days'}, {'measure': "Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test", 'timeFrame': '90 days', 'description': "Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion"}, {'measure': "Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs", 'timeFrame': '90 days'}, {'measure': 'Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results', 'timeFrame': '90 days'}, {'measure': 'Number of target drug-related adverse events over the 90-day period prior to and following PGx testing', 'timeFrame': '90 days'}, {'measure': 'Emergency department visits over the 90-day periods prior to and following PGx testing', 'timeFrame': '90 days'}, {'measure': 'Hospitalizations over the 90-day period prior to and following receipt of PGx test results', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacogenomics', 'Adverse Drug Reactions'], 'conditions': ['Genetics of Drug Metabolism']}, 'descriptionModule': {'briefSummary': 'The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.\n\nThe way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual\'s response to drugs is known as "Pharmacogenomics."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged 65 and above or subjects aged 18 and above who have a disability will be eligible for inclusion in the study if they are receiving or are planned to receive at least one medication with a metabolic pathway linked to genetic variations ("target drug").', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')\n* Males and females aged ≥65 years or male and females aged ≥18 years who have a disability\n* Subject is able and willing to provide written informed consent\n* Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications\n* Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug\n\nExclusion Criteria:\n\n* Subject is currently hospitalized\n* Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results\n* Subject is unable to provide an accurate history due to mental incapacity\n* Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry"}, 'identificationModule': {'nctId': 'NCT02095769', 'acronym': 'POETRY', 'briefTitle': 'Pharmacogenomic Testing Of the Elderly To Reduce Morbidity', 'organization': {'class': 'INDUSTRY', 'fullName': 'General Genetics Corporation'}, 'officialTitle': 'Pharmacogenomic Testing Of the Elderly To Reduce Morbidity', 'orgStudyIdInfo': {'id': '201301'}}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Feldman, MD', 'role': 'CONTACT', 'email': 'eric.feldman@thecoreinstitute.com', 'phone': '623-537-5695'}, {'name': 'Eric Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Core Insitute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven A Brody, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'sbrodymd@lifespan-md.com', 'phone': '858-344-5020'}, {'name': 'Steven A Brody, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LifeSpan Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Gundry, MD', 'role': 'CONTACT', 'email': 'DocSRG@aol.com', 'phone': '760-323-5553'}, {'name': 'Steven Gundry, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The International Heart & Lung Institute Center for Restorative Medicine', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Perry Krichmar, MD', 'role': 'CONTACT', 'email': 'pkrichmar@rpna.net', 'phone': '954-237-6286'}, {'name': 'Perry Krichmar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Physicians Network Alliance', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lutheria Hollis', 'role': 'CONTACT', 'email': 'lhollis@tnc-neuro.com', 'phone': '850-877-5115'}, {'name': 'Matthew Lawson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tallahassee Neurological Institute', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Houston, MD', 'role': 'CONTACT', 'email': 'boohouston@comcast.net', 'phone': '615-512-1481'}, {'name': 'Mark C Houston, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hypertension Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Freemu Varghese, MD', 'role': 'CONTACT', 'email': 'fvarghese@diagnosticclinic.com'}, {'name': 'Freemu Varghese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Diagnostic Clinic of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '00717', 'city': 'Ponce', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Jose Vazquez Tanus, MD', 'role': 'CONTACT', 'email': 'vazqueztanus@me.com', 'phone': '787-290-8585'}, {'name': 'Jose Vazquez Tanus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research & Cardiovascular Corp.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], 'overallOfficials': [{'name': 'Bill Massey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Genetics Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syntactx', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}