Clinical trial NCT06835634: Progressive Advancements in Neurosurgery, Data and Analysis Database
Official title: PANDA, Progressive Advancements in Neurosurgery, Data and Analysis Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spine Disease
Central Nervous System Diseases
Peripheral Nervous System Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: Data collection of adult patients with neurosurgical diseases
timeFrame: 1 year
Secondary outcomes:
measure: database of adult patients with neurosurgical diseases
timeFrame: 1 year
measure: observational research on neurosurgical diseases
timeFrame: 1 year
measure: potential predictors of treatment response
timeFrame: 1 year
measure: development and monitoring of quality indicators
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Alessandro Olivi, MD
role: PRINCIPAL_INVESTIGATOR
References: