Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT06878469
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.
Study:
NCT06878469
Study Brief:
Protocol Section:
NCT06878469