Actively Recruiting
Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline
Led by Tata Memorial Centre · Updated on 2025-04-11
200
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Radiation constitutes an integral component in the management of primary brain tumors in pediatric and young adults like medulloblastoma, ependymoma, low-grade glioma, pituitary tumors, etc. A decline in neurocognitive outcomes is a multifactorial effect occurring from the primary disease as well as associated with treatments, including radiation. Since many of these tumors are highly curable, it is crucial to reduce long-term side effects, including memory loss, to improve the quality of life in these patients, leading to better rehabilitation. Radiation-induced neurocognitive deterioration is postulated to occur from multiple factors like neuroinflammation, vascular damage, and depletion of neural stem cells. The proposed study will prospectively evaluate 200 pediatric and young adults with brain tumors treated with radiotherapy. Biological samples (peripheral blood and cerebrospinal fluid) will be procured during routine investigations (an additional amount will be collected for study purposes without the need for additional investigations). Serial blood markers (whenever available pre-operative and before, during, and after completion of radiation) of neuroinflammation and neural markers will be tested in patients undergoing radiation as part of their standard treatment, and correlate with the neurocognitive outcomes measured by age-appropriate Wechsler intelligence scales. Also, the impact of clinical (e.g. age) and radiotherapy parameters like volume, dose of radiation, and technique (photon versus proton therapy) on acute (during radiotherapy) and late systemic inflammatory markers will be analyzed. The study will even provide the opportunity to know the influence of radiation on systemic neuroinflammatory markers in the human population, providing better biological insights into the neurocognitive decline. If proven successful, these biomarkers can be used in routine clinical practice for early intervention to improve neurocognitive function in patients receiving radiation (even for other histology or other patients receiving radiation like brain metastasis).
CONDITIONS
Official Title
Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 to 39 years
- Diagnosis of primary brain tumor confirmed by tissue analysis
- Planned treatment with radical intent radiotherapy
- Signed assent and parental consent for children or signed consent for adults
You will not qualify if you...
- Unable to complete neurocognitive evaluations
- Receiving palliative radiotherapy
- Expected life expectancy less than 1 year
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital (TMH) Parel, and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Kharghar
Mumbai, Maharashtra, India, 400012,
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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