Clinical trial NCT06878469: SIMPLIFication of Care Pathways for Patients with Rare Brain Tumors Through Artificial Intelligence
Official title: SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients with Rare Brain Tumors Through Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumors
Keywords: Rare brain tumors
neurosurgery
outcomes predictions
Machine Learning
Artificial Intelligence
neurocognitive rehabilitation
innovative models
health care pathways
Astrocytic tumors of CNS
Oligodendroglial tumors of CNS
Ependymal tumors of CNS
Neuronal and mixed neuronal-glial tumors
Choroid plexus carcinoma of CNS
Malignant meningiomas
Embryonal tumors of CNS
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: ASL 1 Avezzano Sulmona L'Aquila
First posted: 2025-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.
Primary purpose: TREATMENT

Brief summary: This study focuses on rare brain tumors, which are heterogeneous entities with different morphological, biological, and clinical characteristics. Due to their rarity, many of these tumors fall under the RARECARE definition of rare tumors. The main objective of the study is to standardize care models and pathways for patients with rare brain tumors, using Artificial Intelligence (AI) and Machine Learning (ML) techniques to identify specific predictors of postoperative outcomes.

The study includes both retrospective and prospective phases, with the collection of clinical, cognitive, and psychological data at various time points. Patients will undergo an early neuro-cognitive rehabilitation program using the RehaCom software, which will be conducted at home. The goal is to improve the quality of life and care for patients through a multidisciplinary and innovative approach.

Detailed description: Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients.

This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (\<6 cases per 100,000 people/year).

The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery).

Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home.

The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors.

The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation.

The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.

Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years)
* Both sexes
* Patients with rare brain tumors (incidence \<6 cases per 100,000 people/year)
* Candidates for craniotomy for rare brain tumors
* Native Italian speakers for cognitive and psychological evaluation and neuro-cognitive rehabilitation

Exclusion Criteria:

* Patients undergoing stereotactic/frameless biopsy
* Patients with psychiatric disorders or on psychotropic medications
* Patients with known cognitive decline (not due to the lesion)
* Patients admitted on the same day as the surgery
* Patients with severe impairments referred to rehabilitation centers
* Patients without a Windows PC or laptop with Internet connection for neuro-cognitive rehabilitation

Primary outcomes:
measure: Symptoms/Signs Onset
timeFrame: Pre-operative
measure: Karnofsky Performance Status (KPS)
timeFrame: Pre-operative, discharge, follow-up at 3, 6, and 12 months.
measure: Neurology Assessment in Neuro-Oncology (NANO)
timeFrame: Pre-operative, discharge, follow-up at 3, 6, and 12 months.
measure: Modified Rankin Scale (mRS)
timeFrame: Pre-operative, discharge, follow-up at 3, 6, and 12 months
measure: American Society of Anesthesiologists (ASA)
timeFrame: Pre-operative
measure: Charlson Comorbidity Index (CCI)
timeFrame: Pre-operative
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Pre-operative, discharge, follow-up at 3, 6, and 12 months.
measure: Eloquent Area Involvement
timeFrame: Intra-operative
measure: Cranial Nerve Manipulation
timeFrame: Intra-operative
measure: Vascular Manipulation
timeFrame: Intra-operative
measure: Extent of Resection
timeFrame: Post-operative immediate
measure: Edema
timeFrame: Pre-operative
measure: Deep Location
timeFrame: Pre-operative
measure: Histology and Molecular Data
timeFrame: Post-operative
measure: Preoperative Neurological Examination (EON)
timeFrame: Pre-operative
measure: Tumor Side
timeFrame: during surgery
measure: Tumor Location
timeFrame: pre-procedure
measure: Cranial Nerve Status
timeFrame: pre-procedure
measure: Cognitive Data Collection: Phonemic Verbal Fluency
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Semantic Verbal Fluency
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection:Token Test
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Digit Span Forward and Backward
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Rey 15-Word List
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Rey Figure Reproduction
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Modified Taylor Complex Figure
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection:Trail Making Test
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Stroop Test
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Mini-Mental State Examination (MMSE)
timeFrame: Pre-operative, discharge, follow-up at 3 and 12 months.
measure: Cognitive Data Collection: Frontal Assessment Battery
timeFrame: Pre-operative, follow-up at 3 and 12 months.
measure: Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Pre-operative, follow-up at 3, 6, 9 and 12 months.
measure: Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Pre-operative, follow-up at 3, 6, 9 and 12 months.
measure: Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasms 20 (EORTC QLQ-BN20)
timeFrame: Pre-operative, follow-up at 3, 6, 9 and 12 months.
measure: Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-operative, follow-up at 3, 6,9 and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: PA
city: L'Aquila
country: Italy
facility: ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Paolo Ferroli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
name: Alessandro Ricci, MD
role: PRINCIPAL_INVESTIGATOR
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