Progressive Advancements in Neurosurgery, Data and Analysis Database (PANDA)

February 14, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PANDA, Progressive Advancements in Neurosurgery, Data and Analysis Database

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection of adult patients with neurosurgical diseases
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Alessandro Olivi, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

February 10, 2035

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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