Progressive Advancements in Neurosurgery, Data and Analysis Database

Active, not recruiting

• Conditions: Spine Disease; Central Nervous System Diseases; Peripheral Nervous System Diseases

• Registration Number: NCT06835634
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2035-02-10
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
database of adult patients with neurosurgical diseases	1 year	To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.
observational research on neurosurgical diseases	1 year	To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.
potential predictors of treatment response	1 year	To identify potential predictors of poor outcomes or treatment response
development and monitoring of quality indicators	1 year	To provide support for the development and monitoring of quality indicators related to patient care.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia; 🇮🇹 Roma, Italy