University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT07226466
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
San Francisco, California, 94143, United States
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
OUTLINE:
This is a single-arm, non-randomized, open-label pilot study. Participants will be study duration spans 12 months post-brain radiotherapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood sample will be collected
Brain MRI will be performed during the course of data collection
Brain Health Assessment will be performed during the course of data collection
QoL questionnaire will be given to participants during the course of data collection
Time frame: Up to 12 months
Mean change in biomarker for Aβ over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for Aβ by APOE genotype over time will be reported
Time frame: Up to 18 months from date of first radiation dose
The EORTC QLQ-BN20 consists of 20 questions; seven single item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness and bladder control), along with four multi-item scales (future uncertainty, visual disorder, motor dysfunction and communication deficit). Raw scores for the QLQ-BN20 items are computed by calculating the mean of the items in each subscale, or the item for each individual and linearly transform the scores to a 0-100 scale. A higher score represents worse QOL for all QLQ-BN20 scales and single items.
Time frame: Up to 12 months
Mean change in biomarker for GFAP over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for GFAP by APOE genotype over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for p-TAU over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for p-TAU by APOE genotype over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for NfL over time will be reported
Time frame: Up to 12 months
Mean change in biomarker for NfL by APOE genotype over time will be reported
Time frame: Up to 12 months
Mean change in of Brain Health Assessment by APOE genotype over time will be reported
Time frame: Up to 12 months
Mean change in Hippocampal Volume as measured by MRI over time will be reported
Time frame: Up to 12 months
Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported
Time frame: Up to 18 months from date of first radiation dose
The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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