SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
NCT06878469, Not applicable, Recruiting, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence | ClinicalTrials.gov |
| NCT number | NCT06878469 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | ClinicalTrials.gov |
| Conditions | Brain Tumors | ClinicalTrials.gov |
| Interventions | RehaCom | ClinicalTrials.gov |
| First posted | 2025-03-17 | ClinicalTrials.gov |
| Last updated | 2026-02-19 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Symptoms/Signs Onset | Pre-operative | Monitoring of headache, seizures, and neurological deficits pre- and post-operatively. Unit of Measure: Number of patients with specific symptoms. | ClinicalTrials.gov |
| Primary | Karnofsky Performance Status (KPS) | 12 months. | 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. | ClinicalTrials.gov |
| Primary | Neurology Assessment in Neuro-Oncology (NANO) | From hospital admission until discharge | 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. | ClinicalTrials.gov |
| Primary | Modified Rankin Scale (mRS) | 12 months | 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. | ClinicalTrials.gov |
| Primary | American Society of Anesthesiologists (ASA) | Pre-operative | 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. | ClinicalTrials.gov |
| Primary | Charlson Comorbidity Index (CCI) | Pre-operative | 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. | ClinicalTrials.gov |
| Primary | Magnetic Resonance Imaging (MRI) | 12 months. | Measurement of tumor size (in cm or mm), location (e.g., frontal lobe, temporal lobe), and side (right, left, bilateral). | ClinicalTrials.gov |
| Primary | Eloquent Area Involvement | Intra-operative | Assessment of whether the tumor involves eloquent brain areas (motor, sensory, language, visual; dominant hemisphere). Unit of Measure: Yes/No. | ClinicalTrials.gov |
| Primary | Cranial Nerve Manipulation | Intra-operative | Evaluation of cranial nerve involvement during surgery. unit of Measure: Yes/No | ClinicalTrials.gov |
| Primary | Vascular Manipulation | Intra-operative | 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 | ClinicalTrials.gov |
| Primary | Extent of Resection | Post-operative immediate | Measurement of the extent of tumor resection (total 100% (GTR), subtotal 90-100% (STR), partial \<90% (PR), open biopsy, needle biopsy | ClinicalTrials.gov |
| Primary | Edema | Pre-operative | Evaluation of the presence and extent of edema (no, perilesional, diffuse), Unit of Measure: Yes/No, extent in cm or mm | ClinicalTrials.gov |
| Primary | Deep Location | Pre-operative | Assessment of whether the tumor is located in deep brain structures (basal ganglia, brainstem, pineal, thalamus, hypothalamus, unit of Measure: Yes/No | ClinicalTrials.gov |
| Primary | Histology and Molecular Data | Post-operative | Histological classification according to WHO 2021, integrated with molecular data | ClinicalTrials.gov |
| Primary | Preoperative Neurological Examination (EON) | Pre-operative | 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 | ClinicalTrials.gov |
| Primary | Tumor Side | during surgery | Side of the tumor (right; left; bilateral; median). | ClinicalTrials.gov |
| Primary | Tumor Location | pre-procedure | 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). | ClinicalTrials.gov |
| Primary | Cranial Nerve Status | pre-procedure | 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). | ClinicalTrials.gov |
| Primary | Cognitive Data Collection: Phonemic Verbal Fluency | 12 months. | 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. | ClinicalTrials.gov |
| Primary | Cognitive Data Collection: Semantic Verbal Fluency | 12 months. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 10
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Token Commands Task | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)