Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 3:40 PM
Study NCT ID:
NCT05548660
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetic-guided Choice of Post-surgery Analgesics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Post-surgery pharmacogenetic-guided analgesic selection versus usual care analgesia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of integrating a PGx panel test in the EMR with a pharmacist consult note for each patient', 'timeFrame': '14 days', 'description': 'The proportion of PGx test results and pharmacist consult notes returned prior to surgery'}, {'measure': 'Fidelity to genotype-guided pharmacotherapy recommendations', 'timeFrame': '14 days', 'description': 'The proportion of medication selections made in agreement with the genotype-guided dosing recommendations for analgesic medications.'}], 'secondaryOutcomes': [{'measure': 'Acute pain - Self-reported numeric pain score', 'timeFrame': '14 days', 'description': 'Mean patient self-reported numeric pain scores (scale: 0-10, 0 = no pain; 10= worst pain imaginable) assessed on POD 0, 3, 7, 14 in the PGx-guided group vs. the control group'}, {'measure': 'Total opioid consumption in morphine milligram equivalents (MME)', 'timeFrame': '14 days', 'description': 'Difference in total MME consumption in variant carriers in PGx-guided group vs. control group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': "Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects or therapeutic failure from analgesics. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing surgeons with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide analgesic choice and improve patient outcomes.\n\nThis is a prospective, two-arm randomized implementation study. Eligible participants will be randomly assigned to receive genotype-guided analgesic selection (intervention arm) or usual care (control arm). Both cohorts will undergo pharmacogenetic testing at the time of consenting. The investigators will primarily measure the feasibility of using this test to guide analgesic selection."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide informed consent\n2. Assigned female at birth and aged 18 years or older at the time of study initiation\n3. Major gynecologic surgery indicated and planned for hysterectomy, myomectomy, exploratory laparotomy, and open abdominal surgery\n4. Willing to provide a buccal swab for PGx testing and comply with all study-related procedures\n\nExclusion Criteria:\n\n1. Receiving chronic opioid therapy defined as ≥ 3 consecutive months of 1-month prescriptions for an opioid\n2. Pregnancy\n3. Breastfeeding\n4. Treating physician does not want subject to participate'}, 'identificationModule': {'nctId': 'NCT05548660', 'acronym': 'PRECISE', 'briefTitle': 'Pharmacogenetic-guided Choice of Post-surgery Analgesics', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Pharmacogenetic-guided Choice of Post-surgery Analgesics', 'orgStudyIdInfo': {'id': '851447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PGx-guided', 'description': 'Pharmacogenetic testing using a 16 gene panel with a pharmacist consult providing genotype-guided recommendations for post-surgery analgesic selection based on CYP2D6 and CYP2C9 results. Pharmacist recommendations for all 16 gene results will also be provided in a detailed note.', 'interventionNames': ['Other: Pharmacogenetic testing', 'Other: Pharmacist note with genotype-guided analgesic recommendations', 'Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines']}, {'type': 'OTHER', 'label': 'Usual care', 'description': 'Pharmacogenetic testing using a 16 gene panel. Post-surgery analgesic selection will be based on usual care (not the PGx results). Pharmacist recommendations for all 16 gene results will be provided in a detailed note with a delayed return of results (30 days post surgery)', 'interventionNames': ['Other: Pharmacogenetic testing', 'Other: Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines']}], 'interventions': [{'name': 'Pharmacogenetic testing', 'type': 'OTHER', 'description': 'Genetic testing of CYP2B6, CYP2C19, CYP2C9, CYP2C cluster CYP2D6, CYP3A5, CYP4F2, DPYD, HLA-A, HLA-B, IFNL4, NUDT15, SLCO1B1, TPMT, UGT1A1, and VKORC1.', 'armGroupLabels': ['PGx-guided', 'Usual care']}, {'name': 'Pharmacist note with genotype-guided analgesic recommendations', 'type': 'OTHER', 'description': 'CYP2C9 normal metabolizers will be recommended to receive ibuprofen and intermediate and poor metabolizers will be recommended to receive naproxen.\n\nCYP2D6 normal metabolizers will be recommended to receive tramadol and ultrarapid, intermediate and poor metabolizers will be recommended to receive oxycodone.', 'armGroupLabels': ['PGx-guided']}, {'name': 'Pharmacist detailed note with genotype-guided recommendations per CPIC guidelines', 'type': 'OTHER', 'description': 'Genotype-guided recommendations for all actionable phenotypes resulted from the 16-gene PGx panel per CPIC guidelines and FDA labeling', 'armGroupLabels': ['PGx-guided', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study protocol, SAP, ICF will be made available 1 year following enrollment of the last participant. IPD will be made available 6 months after publication of study results', 'ipdSharing': 'YES', 'description': 'Data will be made available upon reasonable request.', 'accessCriteria': 'Contact PI, Sony Tuteja, PharmD, sonyt@pennmedicine.upenn.edu with individual requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor of Medicine, Division of Translational Medicine and Human Genetics; Assistant Director, Pharmacogenomics Penn Center for Precision Medicine', 'investigatorFullName': 'Sony Tuteja', 'investigatorAffiliation': 'University of Pennsylvania'}}}}