Clinical trial · Interventional
SIMPLIFication of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
SIMPLIF-AI: SIMPLIFication and Standardization of Care Pathways for Patients With Rare Brain Tumors Through Artificial Intelligence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RehaCom | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group
- description
- This group includes all adult participants with rare brain tumors who will receive early neuro-cognitive rehabilitation using the RehaCom software.
- interventionNames
- Device: RehaCom
Primary outcomes (33)
- measure
- Symptoms/Signs Onset
- timeFrame
- Pre-operative
- description
- Monitoring of headache, seizures, and neurological deficits pre- and post-operatively. Unit of Measure: Number of patients with specific symptoms.
- measure
- Karnofsky Performance Status (KPS)
- timeFrame
- 12 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDFan FL, Xiong J, Li M, Wang G. On Interpretability of Artificial Neural Networks: A Survey. IEEE Trans Radiat Plasma Med Sci. 2021 Nov;5(6):741-760. doi: 10.1109/trpms.2021.3066428. Epub 2021 Mar 17. PMID 35573928
- BACKGROUNDSagberg LM, Drewes C, Jakola AS, Solheim O. Accuracy of operating neurosurgeons' prediction of functional levels after intracranial tumor surgery. J Neurosurg. 2017 Apr;126(4):1173-1180. doi: 10.3171/2016.3.JNS152927. Epub 2016 Jun 17. PMID 27315026
- BACKGROUNDLopez-Nunez O, Alaggio R, John I, Ciolfi A, Pedace L, Mastronuzzi A, Gianno F, Giangaspero F, Rossi S, Donofrio V, Cinalli G, Surrey LF, Tartaglia M, Locatelli F, Miele E. Melanotic Neuroectodermal Tumor of Infancy (MNTI) and Pineal Anlage Tumor (PAT) Harbor A Medulloblastoma Signature by DNA Methylation Profiling. Cancers (Basel). 2021 Feb 9;13(4):706. doi: 10.3390/cancers13040706. PMID 33572349
- BACKGROUNDBunevicius A, Tamasauskas S, Deltuva V, Tamasauskas A, Radziunas A, Bunevicius R. Predictors of health-related quality of life in neurosurgical brain tumor patients: focus on patient-centered perspective. Acta Neurochir (Wien). 2014 Feb;156(2):367-74. doi: 10.1007/s00701-013-1930-7. Epub 2013 Nov 20. PMID 24254135
- BACKGROUNDRolston JD, Han SJ, Lau CY, Berger MS, Parsa AT. Frequency and predictors of complications in neurological surgery: national trends from 2006 to 2011. J Neurosurg. 2014 Mar;120(3):736-45. doi: 10.3171/2013.10.JNS122419. Epub 2013 Nov 22. PMID 24266542
- BACKGROUNDBroggi M, Zattra C, Ferroli P. How to compare outcomes and complications in neurosurgery: We must make the mission possible! Surg Neurol Int. 2018 Mar 19;9:65. doi: 10.4103/sni.sni_424_17. eCollection 2018. No abstract available. PMID 29629232
- BACKGROUNDFerroli P, Broggi M, Schiavolin S, Acerbi F, Bettamio V, Caldiroli D, Cusin A, La Corte E, Leonardi M, Raggi A, Schiariti M, Visintini S, Franzini A, Broggi G. Predicting functional impairment in brain tumor surgery: the Big Five and the Milan Complexity Scale. Neurosurg Focus. 2015 Dec;39(6):E14. doi: 10.3171/2015.9.FOCUS15339.