Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-01-31 @ 8:42 PM
Study NCT ID:
NCT02485795
Status:
UNKNOWN
Last Update Posted:
2017-06-01
First Post:
2015-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Pain Numeric Rating Scale (NRS)', 'timeFrame': '60 days'}, {'measure': 'Function/Disability assessment on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '60 days'}, {'measure': 'Number of Participants that Experience of Adverse Events', 'timeFrame': 'Up to 2 years'}, {'measure': 'Type of Adverse Events Experienced by Participants', 'timeFrame': 'Up to 2 years'}, {'measure': 'Severity of Adverse Events Experienced by Participants', 'timeFrame': 'Up to 2 years'}, {'measure': 'Type of treatments selected for participants', 'timeFrame': '60 days'}, {'measure': 'Medication dosage prescribed to the participants', 'timeFrame': '60 days'}, {'measure': 'Frequency of participant urine drug screens', 'timeFrame': '60 days'}, {'measure': 'Self-rated response levels to prescribed medications', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Co-occurring disorders reported by ICD-9/10 code', 'timeFrame': '60 days'}, {'measure': 'Assessment of previous treatments', 'timeFrame': '60 days'}, {'measure': 'Urine drug screen results', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Genetic Variation', 'Genetic Polymorphism', 'Polymorphism, Single Nucleotide Genetic Association Studies', 'Healthcare Utilization'], 'conditions': ['Pain', 'Chronic Pain', 'Back Pain', 'Nociceptive Pain', 'Neuropathic Pain', 'Musculoskeletal Pain', 'Neck Pain', 'Pain, Intractable']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes in interventional pain management clinical care. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.', 'detailedDescription': "Specific genetic variations have been identified that result in alteration of expression or function of receptors, enzymes, and transporters that are relevant to the safety and efficacy of a medical treatment. By providing information regarding the genetic risks and the most effective therapy for an individual patient, clinicians may improve the efficacy of treatment and decrease the risk of adverse events.\n\nThe purpose of this study is to evaluate how currently available genetic tests are being implemented in various interventional pain management clinics around the United States, and whether this information results in benefits to patient care. Considering patient genotype correlates with pain sensitivity and perception, as well as autonomic nervous system dysfunction due to variations in sodium and potassium channels, genotypic associations can significantly improve outcomes in interventional pain management modalities including:\n\n* Injections (also called nerve blocks using medications), such as steroids and opioids, including epidural steroid injections, facet joint injections, single nerve root blocks, and sacroiliac joint injections;\n* Radiofrequency Rhizotomy (radiofrequency ablation and neuroablation), using x-ray guidance and a needle with an electrode at the tip that gets heated, to temporarily turn off a nerve's ability to send pain messages to the brain; and,\n* Intrathecal pump implants which provide potent medications straight to the source of pain.\n\nPatient that are receiving Proove Bioscience's genetic testing will complete validated questionnaires to measure specific outcomes related to their treatment at each clinical visit, including medication efficacy, reduction in adverse drug events, and healthcare utilization. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments, and any improvements in the outcome measures. Statistical analysis will be performed to calculate relationships between genotypic and phenotypic data points collected in this study.\n\nThe results of this study will provide a measurable understanding of the medical and economic value of implementing genetic testing into interventional pain management. Furthermore, data points collected will be used to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal clinical outcome measures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be adult patients who are candidates for interventional pain management treatments, including Injections, Radio-frequency, Intrathecal pump implants, etc. All patients are receiving routine medical visits for their care and will have Proove laboratory genetic testing performed.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provide signed and dated informed consent form\n* Willing to comply with all study procedures and be available for the duration of the study\n* Male or Female, at least 18 years of age\n* Currently taking or a candidate for opioid pain medication\n* Documented or recent complaint of pain within 90 days (location to be documented in the case report form) with initial date of onset\n\nExclusion Criteria:\n\n* Severe hepatic or renal disease (where current pharmaceutical dosing is affected and/or requires adjustment of standard dosing prior to PGx testing)\n* Significant diminished mental capacity that is unable to understand the protocol, surveys and questionnaires; unable to read/write English or Spanish.\n* Recent febrile illness that precludes or delays participation by more than 1 month\n* Pregnancy or lactation\n* Participation in a clinical study that may interfere with participation in this study\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study"}, 'identificationModule': {'nctId': 'NCT02485795', 'acronym': 'MOSAIC', 'briefTitle': 'Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Proove Bioscience, Inc.'}, 'officialTitle': 'A Multicenter Longitudinal Observational Study Evaluating Genotypic Association wIth Clinical Outcomes in Interventional Pain Management Modalities', 'orgStudyIdInfo': {'id': 'PB007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pain patients', 'description': 'Observational; Patients presenting to interventional pain management centers for therapy.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.', 'armGroupLabels': ['Pain patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86301', 'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Arizona Pain Institute', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'zip': '72543', 'city': 'Heber Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Spine Specialty Clinic of Arkansas', 'geoPoint': {'lat': 35.49147, 'lon': -92.03126}}, {'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Steven J. Waltrip M.D. Inc.', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Nuvo Spine', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Orthopaedic Surgical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90948', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Snibbe Orthopedics', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Pain Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Anuj Gupta', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrated Pain Solutions of South FL', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'country': 'United States', 'facility': 'Spinal Interventional Research', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '33462', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Stuart B Krost MD', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '32407', 'city': 'Panama City Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Panama Interventional Pain Management', 'geoPoint': {'lat': 30.17659, 'lon': -85.80549}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Interventional Pain Physicians of South Florida', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Neurological Spine & Pain', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '47203', 'city': 'Columbus', 'state': 'Indiana', 'country': 'United States', 'facility': 'Wellspring Pain Solutions', 'geoPoint': {'lat': 39.20144, 'lon': -85.92138}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Compass Pain Care', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Pain Management', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dr. Todd Joye', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29579', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Interventional Pain Associates', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '29588', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pain, Spine and Sports Medicine', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '29588', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Spine and Pain Care Consultants', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Orthopaedic Surgery Group', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Centre Pain Mgmt', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77050', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'TX Spine and Joint', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'KSF Orthopaedic Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'North Hills Pain', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '77380', 'city': 'Shenandoah', 'state': 'Texas', 'country': 'United States', 'facility': 'The Woodlands Pain Institute', 'geoPoint': {'lat': 30.18022, 'lon': -95.45577}}, {'zip': '77904', 'city': 'Victoria', 'state': 'Texas', 'country': 'United States', 'facility': 'Victoria Pain and Rehabilitation Center', 'geoPoint': {'lat': 28.80527, 'lon': -97.0036}}, {'zip': '22102', 'city': 'McLean', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Spine And Pain Centers', 'geoPoint': {'lat': 38.93428, 'lon': -77.17748}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Spine and Pain Medicine', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Maneesh Sharma, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interventional Pain Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proove Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}