Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer (NCT07226466) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
United States40 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>= 18 years old
. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.
. Diagnosis of primary solid tumor and secondary involvement of the brain
. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \> 1 cm in max diameter.
. Candidate for standard of care / usual care (SOC) focused brain radiotherapy.
. No prior brain radiotherapy, including whole brain radiotherapy.
. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is tracking blood proteins like amyloid-beta, tau, and GFAP — which are also associated with Alzheimer's disease — so could you explain what finding changes in these markers might actually mean for my brain health, and how that information would affect my care?
2The trial also looks at how someone's APOE gene type influences these biomarker changes — do you know my APOE genotype, and is that something worth discussing in the context of my brain tumor treatment?
3Since this study is listed as 'not yet recruiting,' how long might it realistically be before it opens, and is there a comparable observational study I could participate in now while we wait for my treatment decisions to be made?
4The trial measures hippocampal volume over time, which is linked to memory and cognitive function — given my specific diagnosis, is my hippocampus already at risk from the tumor itself, from planned treatment, or both, and how does this study help answer that question for patients like me?
5This appears to be an observational study measuring changes rather than testing a new treatment — can you help me understand whether joining this trial would run alongside my standard cancer care, or whether it changes or delays any treatment I would otherwise receive?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in serum Amyloid-beta peptide (Aβ)
Timeframe: Up to 12 months
2
Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype
Timeframe: Up to 12 months
3
Mean change of score on the European Organization for Research and Treatment of Cancer quality of life questionnaire - Brain Module (EORTC-QLQ-BN20)
Timeframe: Up to 18 months from date of first radiation dose
4
Mean change in serum Glial Fibrillary Acidic Protein (GFAP)
Timeframe: Up to 12 months
5
Mean change in serum Glial Fibrillary Acidic Protein (GFAP) by APOE genotype
Timeframe: Up to 12 months
6
Mean change in serum Phosphorylated TAU (p-TAU)
Timeframe: Up to 12 months
7
Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotype