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Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

ConditionsBrain Tumor AdultBrain Metastases From Solid TumorsBrain Tumor, PrimaryBrain Tumor
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>= 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.

Disqualifiers

Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).

Diagnosis of memory disorder pre-treatment.

Leptomeningeal disease or disease involving either hippocampus.

Trial population

Adult participants with brain cancers receiving care at University of California, San Francisco (UCSF)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Procedure/Surgery

    Blood sample will be collected

  • Brain magnetic resonance imaging (MRI)

    Procedure/Surgery

    Brain MRI will be performed during the course of data collection

  • Brain Health Assessment

    Procedure/Surgery

    Brain Health Assessment will be performed during the course of data collection

  • Quality of Life (QoL) Questionnaire

    Radiation

    QoL questionnaire will be given to participants during the course of data collection

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Adults with Brain Tumor Receiving Radiotherapy4 interventions

Trial outcomes

Primary outcomes

1

Mean change in serum Amyloid-beta peptide (Aβ)

Mean change in biomarker for Aβ over time will be reported

Time frame
Up to 12 months
2

Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype

Mean change in biomarker for Aβ by APOE genotype over time will be reported

Time frame
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)

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 18 months from date of first radiation dose
4

Mean change in serum Glial Fibrillary Acidic Protein (GFAP)

Mean change in biomarker for GFAP over time will be reported

Time frame
Up to 12 months

Secondary outcomes

1

Change in scores on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) over time

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.

Time frame
Up to 18 months from date of first radiation dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: