Clinical trial · Observational
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
NCT07226466CI-TRIAL-00122578not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases From Solid Tumors | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Procedure | — | UNRESOLVED |
| Brain Health Assessment | Procedure | — | UNRESOLVED |
| Brain magnetic resonance imaging (MRI) | Procedure | — | UNRESOLVED |
| Quality of Life (QoL) Questionnaire | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with Brain Tumor Receiving Radiotherapy
- description
- The study entails longitudinal assessment of plasma biomarkers (Aβ, GFAP, phospho Tau, NfL), determination of APOE genotype, neuropsychiatric testing Brain Health Assessment test (BHA), a clinically validated neurocognitive battery compiling metrics on memory and language), and brain morphometric measurements synchronized with standard of care brain MRIs.
- interventionNames
- Procedure: Blood sample
- Procedure: Brain magnetic resonance imaging (MRI)
- Procedure: Brain Health Assessment
- Radiation: Quality of Life (QoL) Questionnaire
Primary outcomes (12)
- measure
- Mean change in serum Amyloid-beta peptide (Aβ)
- timeFrame
- Up to 12 months
- description
- Mean change in biomarker for Aβ over time will be reported
- measure
- Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. \>= 18 years old 2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3. 3. Diagnosis of primary solid tumor and secondary involvement of the brain 4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \> 1 cm in max diameter. 5. Candidate for standard of care / usual care (SOC) focused brain radiotherapy. 6. No prior brain radiotherapy, including whole brain radiotherapy. 7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1. 8. Estimated life expectancy post-treatment of \> 2 years. Exclusion Criteria: 1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease). 2. Diagnosis of memory disorder pre-treatment. 3. Leptomeningeal disease or disease involving either hippocampus.
References
Publications (0)
Data not yet available
No reference posted for this study.