Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 1:34 PM
Study NCT ID:
NCT06835634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progressive Advancements in Neurosurgery, Data and Analysis Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data collection of adult patients with neurosurgical diseases', 'timeFrame': '1 year', 'description': 'To establish a prospective data collection of adult patients with neurosurgical diseases, providing real-life data on the current management of patients at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and the participating centers.'}], 'secondaryOutcomes': [{'measure': 'database of adult patients with neurosurgical diseases', 'timeFrame': '1 year', 'description': 'To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.'}, {'measure': 'observational research on neurosurgical diseases', 'timeFrame': '1 year', 'description': 'To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.'}, {'measure': 'potential predictors of treatment response', 'timeFrame': '1 year', 'description': 'To identify potential predictors of poor outcomes or treatment response'}, {'measure': 'development and monitoring of quality indicators', 'timeFrame': '1 year', 'description': 'To provide support for the development and monitoring of quality indicators related to patient care.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spine Disease', 'Central Nervous System Diseases', 'Peripheral Nervous System Diseases']}, 'descriptionModule': {'briefSummary': 'Neurosurgical diseases encompass a highly heterogeneous group of conditions, including oncological, malformative, traumatic, spinal, vascular, infectious diseases, and cerebrospinal fluid dynamics disorders. Several systematic reviews on the level of evidence in neurosurgical diseases have documented the low percentage of high-quality scientific evidence in this field of medicine. Clinical practice is strongly influenced by individual physician preferences, leading to significant heterogeneity among different centers both in Italy and internationally. This overall picture highlights the need for tools that can accurately characterize the numerous diagnostic variables influencing therapeutic outcomes in patients with neurosurgical diseases.\n\nPrimary Objective To establish a prospective data collection of adult patients with neurosurgical diseases, providing real-life data on the current management of patients at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and the participating centers.\n\nSecondary Objectives To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.\n\nTo conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.\n\nTo identify potential predictors of poor outcomes or treatment response. To assess the clinical history and treatment response of patients, including for internal audit purposes (e.g., supporting Morbidity \\& Mortality conferences).\n\nTo provide support for the development and monitoring of quality indicators related to patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population affected by a \\*\\*neurosurgical disease\\*\\* at the time of \\*\\*first contact with the patient\\*\\*, whether in an \\*\\*outpatient or inpatient setting\\*\\*, at the facilities of the centers participating in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at first contact equal to or greater than 18 years at the time of informed consent signature.\n* Diagnosis of a neurosurgical disease.\n\nExclusion Criteria:\n\n* Refusal to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT06835634', 'acronym': 'PANDA', 'briefTitle': 'Progressive Advancements in Neurosurgery, Data and Analysis Database', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'PANDA, Progressive Advancements in Neurosurgery, Data and Analysis Database', 'orgStudyIdInfo': {'id': '7202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Self reported questionnaires', 'type': 'PROCEDURE', 'otherNames': ['psychological tests'], 'description': 'PROMs and psychological tests submission in patients affected by neurosurgical diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Alessandro Olivi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}