Identifying biomarkers to predict cognitive decline after radiation therapy for brain tumors
Systemic Biomarkers to Predict Radiation-Induced Neurocognitive Decline in Pediatric and Young Adults With Primary Brain Tumors (BIO-RIN)
This study is trying to find specific markers in blood and spinal fluid from young patients with brain tumors to see if they can predict problems with thinking and memory after radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 5 Years to 39 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | Radiation, chemotherapy |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06779487 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate systemic biomarkers in pediatric and young adult patients with brain tumors who are undergoing radiotherapy. It will involve collecting biological samples, including peripheral blood and cerebrospinal fluid, at various stages of treatment and follow-up. The study will analyze these samples for markers of neuroinflammation and other factors that may contribute to cognitive decline post-radiation. By understanding these biomarkers, the study seeks to improve the quality of life for patients by potentially mitigating long-term neurocognitive side effects.
Who should consider this trial
Good fit: Ideal candidates are pediatric and young adult patients aged 5-39 years with a histological diagnosis of primary brain tumors who are set to receive radical intent radiotherapy.
Not a fit: Patients who are receiving palliative radiotherapy or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preserving cognitive function in young patients undergoing radiation therapy for brain tumors.
How similar studies have performed: While there have been studies exploring neurocognitive outcomes in brain tumor patients, the specific focus on systemic biomarkers in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mumbai, Maharashtra
- Tata Memorial Hospital (TMH) Parel, and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Kharghar — Mumbai, Maharashtra, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.