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Active, not recruiting Observational

Progressive Advancements in Neurosurgery, Data and Analysis Database

NCT06835634 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-15
Last updated
2025-02-19

Condition(s) studied

Spine DiseaseCentral Nervous System DiseasesPeripheral Nervous System Diseases

Investigational drug(s) / intervention(s)

Self reported questionnaires

Self reported questionnaires: PROMs and psychological tests submission in patients affected by neurosurgical diseases

Study summary

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.

Primary 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.

Secondary Objectives To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.

To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.

To 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).

To provide support for the development and monitoring of quality indicators related to patient care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age at first contact equal to or greater than 18 years at the time of informed consent signature. * Diagnosis of a neurosurgical disease. Exclusion Criteria: * Refusal to provide written informed consent.

Primary outcome measure(s)

  • Data collection of adult patients with neurosurgical diseases — 1 year
    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.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia Roma Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835634 on ClinicalTrials.gov ↗ ← All trials in Italy