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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Participants will receive a personalized neuro-cognitive rehabilitation program using the RehaCom software. Sessions will last approximately 30/40 minutes and will be held twice a week for 8 weeks. The rehabilitation will be aimed at enhancing and/or recovering cognitive functions that may have been compromised by the neurosurgical intervention.
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, PA, Italy
RECRUITINGASL 1 Abruzzo Avezzano-Sulmona-L'Aquila
L’Aquila, Italy
NOT_YET_RECRUITINGSymptoms/Signs Onset
Monitoring of headache, seizures, and neurological deficits pre- and post-operatively. Unit of Measure: Number of patients with specific symptoms.
Time frame: Pre-operative
Karnofsky Performance Status (KPS)
Karnofsky Performance Status (KPS) score - Assessment of functional capacity on a scale from 0 to 100, where 100 indicates no symptoms and full activity, and 0 indicates death.
Time frame: 12 months.
Neurology Assessment in Neuro-Oncology (NANO)
NANO scale score - Evaluation of neurological function using the Neurological Assessment in Neuro-Oncology (NANO) scale, which assesses nine clinically relevant domains: gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior. Each domain is scored from 0 to 4, with higher scores indicating greater impairment.
Time frame: From hospital admission until discharge
Modified Rankin Scale (mRS)
Disability score (0-6) - Measurement of disability or dependence in daily activities on a scale from 0 to 6, where 0 indicates no symptoms and 6 indicates death.
Time frame: 12 months
American Society of Anesthesiologists (ASA)
Assessment of the patient's physical status before surgery using the ASA classification system. This system categorizes patients based on their overall health and the presence of systemic diseases. ASA classification score from I to VI, with higher scores indicating greater severity of systemic disease and higher perioperative risk.
Time frame: Pre-operative
Charlson Comorbidity Index (CCI)
The CCI evaluates comorbid conditions to predict ten-year mortality. It includes 17 categories of comorbidities, such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, hemiplegia, chronic kidney disease, solid tumor, leukemia, lymphoma, and AIDS. Each condition is assigned a score based on its associated risk of mortality. The total score is the sum of the individual scores for each condition, with higher scores indicating a greater number of comorbid conditions and higher predicted mortality.
Time frame: Pre-operative
Magnetic Resonance Imaging (MRI)
Measurement of tumor size (in cm or mm), location (e.g., frontal lobe, temporal lobe), and side (right, left, bilateral).
Time frame: 12 months.
Eloquent Area Involvement
Assessment of whether the tumor involves eloquent brain areas (motor, sensory, language, visual; dominant hemisphere). Unit of Measure: Yes/No.
Time frame: Intra-operative
Cranial Nerve Manipulation
Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No
Time frame: Intra-operative
Vascular Manipulation
Assessment of vascular involvement during surgery (specify vessels: ICA, ACA, MCA, Acom, PcomA, anterior choroidal, ophthalmic, vertebral, basilar, PICA, AICA, SCA, posterior cerebral; superior sagittal sinus, transverse, sigmoid, straight, internal cerebral veins, vein of Galen, Labbe, Trolard. unit of Measure: Yes/No
Time frame: Intra-operative
Extent of Resection
Measurement of the extent of tumor resection (total 100% (GTR), subtotal 90-100% (STR), partial \<90% (PR), open biopsy, needle biopsy
Time frame: Post-operative immediate
Edema
Evaluation of the presence and extent of edema (no, perilesional, diffuse), Unit of Measure: Yes/No, extent in cm or mm
Time frame: Pre-operative
Deep Location
Assessment of whether the tumor is located in deep brain structures (basal ganglia, brainstem, pineal, thalamus, hypothalamus, unit of Measure: Yes/No
Time frame: Pre-operative
Histology and Molecular Data
Histological classification according to WHO 2021, integrated with molecular data
Time frame: Post-operative
Preoperative Neurological Examination (EON)
Description of deficits (none; motor; sensory; cognitive; language; cranial nerves; intracranial hypertension; epilepsy; hormonal/hypothalamic disturbances; optic pathways; cerebellar, unit of Measure: Type of deficit
Time frame: Pre-operative
Tumor Side
Side of the tumor (right; left; bilateral; median).
Time frame: during surgery
Tumor Location
Location of the tumor (frontal, Rolandic, Broca, insular, temporal, parietal, occipital, intraventricular (lateral only), third ventricle, sella, sella+suprasellar/parasellar, clivus, optic+optic pathways, orbit, petroclival, cavernous sinus, planum/olfactory grooves, clinoid, falx, cerebellar, cerebellopontine angle, medulla, pons, midbrain, fourth ventricle, foramen magnum, pineal).
Time frame: pre-procedure
Cranial Nerve Status
Status of cranial nerves I-XII (normal; deficit), House-Brackmann scale for cranial nerve VII (1-5), hearing status for cranial nerve VIII (useful hearing; non-useful hearing), status of cranial nerves IX-X (normal; deficit; tracheostomy; PEG).
Time frame: pre-procedure
Cognitive Data Collection: Phonemic Verbal Fluency
Assessment of verbal fluency by asking patients to generate as many words as possible beginning with a specific letter within a set time limit. Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Time frame: 12 months.
Cognitive Data Collection: Semantic Verbal Fluency
Assessment of verbal fluency by asking patients to generate as many words as possible within a specific category (e.g., animals) within a set time limit. Unit of Measure: Number of words generated. Higher scores indicate better verbal fluency.
Time frame: 12 months.
Cognitive Data Collection:Token Test
Assessment of language comprehension by asking patients to follow verbal instructions involving tokens of different shapes, sizes, and colors. Unit of Measure: Higher scores indicate better language comprehension.
Time frame: 12 months.
Cognitive Data Collection: Digit Span Forward and Backward
Assessment of working memory by asking patients to repeat a sequence of numbers in the same order (forward) and in reverse order (backward). Unit of Measure: Number of digits correctly recalled. Higher scores indicate better working memory.
Time frame: 12 months.
Cognitive Data Collection: Rey 15-Word List
Assessment of verbal memory by asking patients to recall a list of 15 words immediately after presentation and after a delay. Unit of Measure: Number of words correctly recalled. Higher scores indicate better verbal memory.
Time frame: 12 months.
Cognitive Data Collection: Rey Figure Reproduction
Assessment of visuospatial memory by asking patients to reproduce a complex figure from memory. Unit of Measure: Score on the Rey Figure Reproduction. Higher scores indicate better visuospatial memory.
Time frame: 12 months.
Cognitive Data Collection: Modified Taylor Complex Figure
Assessment of visuospatial construction and memory by asking patients to copy and then reproduce a complex figure from memory. Unit of Measure: Score on the Modified Taylor Complex Figure. Higher scores indicate better visuospatial construction and memory.
Time frame: Pre-operative, follow-up at 3 and 12 months.
Cognitive Data Collection:Trail Making Test
Assessment of attention and task-switching by asking patients to connect a sequence of numbered and lettered circles as quickly as possible. Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Time frame: Pre-operative, follow-up at 3 and 12 months.
Cognitive Data Collection: Stroop Test
Assessment of cognitive flexibility and processing speed by asking patients to name the color of the ink in which a word is printed, which may differ from the word itself (e.g., the word "red" printed in blue ink). Unit of Measure: Time taken to complete the task. Lower times indicate better performance.
Time frame: 12 months.
Cognitive Data Collection: Mini-Mental State Examination (MMSE)
Assessment of general cognitive function, including orientation, registration, attention and calculation, recall, and language. Unit of Measure: Score on the MMSE (0-30). Higher scores indicate better cognitive function.
Time frame: 12 months.
Cognitive Data Collection: Frontal Assessment Battery
Assessment of executive functions, including conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. Unit of Measure: Score on the FAB (0-18). Higher scores indicate better executive function.
Time frame: 12 months.
Psychological and Quality of Life Data Collection: WHO Disability Assessment Schedule (WHODAS 2.0)
Assessment of disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). This tool evaluates six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: 12 months.
Psychological and Quality of Life Data Collection: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Assessment of quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This 30-item questionnaire measures various aspects of quality of life in cancer patients, including physical, role, cognitive, emotional, and social functioning, as well as symptoms and global health status. Higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate worse symptoms
Time frame: 12 months.
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)
Assessment of quality of life specific to brain tumor patients using the EORTC QLQ-BN20. This module evaluates symptoms and issues relevant to brain tumor patients, such as future uncertainty, visual disorders, motor dysfunction, and communication deficits. Higher scores indicate worse symptoms or issues.
Time frame: 12 months.
Psychological and Quality of Life Data Collection: Hospital Anxiety and Depression Scale (HADS)
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). This 14-item tool produces two subscales: HADS-A (anxiety) and HADS-D (depression). Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety or depression.
Time frame: 12 months.
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