RecruitingNCT06779487

Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline

Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline in Pediatric and Young Adults With Primary Brain Tumors (BIO-RIN)


Sponsor

Tata Memorial Centre

Enrollment

200 participants

Start Date

Feb 11, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 5 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for biological markers in the blood that can predict which patients will experience memory and thinking problems (neurocognitive decline) after radiation therapy for a brain tumor. If researchers can identify who is at highest risk, doctors may be able to better protect those patients during treatment. **You may be eligible if...** - You are between 5 and 39 years old - You have been diagnosed with a primary brain tumor - Your doctor has decided you will receive radiation therapy with the intent to cure - You are able to complete thinking and memory testing **You may NOT be eligible if...** - You cannot undergo cognitive (thinking and memory) evaluation - You are receiving radiation therapy only to manage symptoms (palliative), not to cure - Your expected survival is less than one year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Tata Memorial Hospital (TMH) Parel, and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Kharghar

Mumbai, Maharashtra, India

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NCT06779487


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