NCT06779487 Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline
| NCT ID | NCT06779487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Brain Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2032-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-02-11 with a primary completion date of 2032-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age 5-39 years 2. Histological diagnosis of primary brain tumor 3. Decision for treatment with radical intent radiotherapy 4. Signed assent and parental consent form for pediatric age group and signed consent form for adults. Exclusion Criteria: 1. Inability to undergo neurocognitive evaluation 2. Palliative radiotherapy. 3. Expected life expectancy \< 1 year
Frequently Asked Questions
Who can join the NCT06779487 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 39 Years, studying Brain Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06779487 currently recruiting?
Yes, NCT06779487 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tata Memorial Centre to inquire about joining.
Where is the NCT06779487 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06779487 clinical trial?
NCT06779487 is sponsored by Tata Memorial Centre. The trial plans to enroll 200 participants.