Spine DiseasePANDANCT06835634
Progressive Advancements in Neurosurgery, Data and Analysis Database
An observational study of Spine Disease and Central Nervous System Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Neurosurgical diseases encompass a highly heterogeneous group of conditions, including oncological, malformative, traumatic, spinal, vascular, infectious diseases, and cerebrospinal fluid dynamics disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Disease, Central Nervous System Diseases, Peripheral Nervous System Diseases
- What is being tested?
- Self reported questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 7,500 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2025to 31 Dec 2035
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age at first contact equal to or greater than 18 years at the time of informed consent signature.
- Diagnosis of a neurosurgical disease.
Who cannot join
- Refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurochirurgia
Roma, 00168
About this study
Official title: 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.
Read more
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.
- Being tested
- Self reported questionnaires
- Medical subject headings
- Spinal Diseases, Central Nervous System Diseases, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self reported questionnairesProcedure or surgery
Also called psychological tests
PROMs and psychological tests submission in patients affected by neurosurgical diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
database of adult patients with neurosurgical diseases
To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.
Measured: 1 year
observational research on neurosurgical diseases
To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.
Measured: 1 year
potential predictors of treatment response
To identify potential predictors of poor outcomes or treatment response
Measured: 1 year
development and monitoring of quality indicators
To provide support for the development and monitoring of quality indicators related to patient care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start15 Jan 2025
- Primary completion10 Feb 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Olivi, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835634
- Sponsor's protocol ID
- 7202
- Acronym
- PANDA
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANDA, Progressive Advancements in Neurosurgery, Data and Analysis Database
- ClinicalTrials.gov ID
- NCT06835634
- Acronym / sponsor ID
- PANDA / 7202
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 10 Feb 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age at first contact equal to or greater than 18 years at the time of informed consent signature.
- Diagnosis of a neurosurgical disease.
Key exclusion criteria (1 listed)
- Refusal to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self reported questionnairesAlso: psychological testsPROMs and psychological tests submission in patients affected by neurosurgical diseases | Procedure or surgery | – |
Primary outcome
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.
4 secondary outcomes
database of adult patients with neurosurgical diseases
Time frame: 1 year
observational research on neurosurgical diseases
Time frame: 1 year
potential predictors of treatment response
Time frame: 1 year
development and monitoring of quality indicators
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Olivi, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Disease and Central Nervous System Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection of adult patients with neurosurgical diseases (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.