Progressive Advancements in Neurosurgery, Data and Analysis Database

NCT06835634 | Active Not Recruiting

• 1 other identifier: 7202
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Disease; Central Nervous System Diseases; Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• Data collection of adult patients with neurosurgical diseases

  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.

  1 year

Secondary Outcomes (4)

• database of adult patients with neurosurgical diseases

  1 year

• observational research on neurosurgical diseases

  1 year

• potential predictors of treatment response

  1 year

• development and monitoring of quality indicators

  1 year

Interventions

Self reported questionnaires PROCEDURE

PROMs and psychological tests submission in patients affected by neurosurgical diseases

Also known as: psychological tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age at first contact equal to or greater than 18 years at the time of informed consent signature.
• Diagnosis of a neurosurgical disease.

You may not qualify if:

• Refusal to provide written informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Spinal Diseases; Central Nervous System Diseases; Peripheral Nervous System Diseases

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Alessandro Olivi, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): February 10, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

IT (1)