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Bioenergetic Profiling and Cognition in GBM Patients

NCT03939858 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2023-11-08

No results posted yet for this study

Summary

This trial studies the use of blood-based bioenergetic profiling and cognitive testing in assessing patients with glioblastoma undergoing chemoradiation therapy. The purpose of this pilot research study is to find out if it is possible to see changes in participants' mitochondria, parts of a cell that produce energy, that might be associated with changes in participants' brain function after chemoradiation therapy.

Conditions

Interventions

PROCEDURE

Cognitive Assessment

Tests have been selected to represent a range of cognitive functions affected by cancer and radiotherapy including basic attention, recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills.

DIAGNOSTIC_TEST

Blood Collection

16 ml of blood will be collected before 10 a.m. and after the participant has fasted for 8 hours. White blood cells and platelets will be used for respirometric analysis. Plasma will be additionally processed and saved in 500uL aliquots(x2) and the remainder in 1mL aliquots at -80°C.

DIAGNOSTIC_TEST

Bioenergetic Profiling

Peripheral blood mononuclear cells (PBMCs) and platelets will be separated from the blood. Primary respirometric parameters will be measured with high-throughput respirometry using the Agilent Seahorse 24XFe. Additional parameters will be collected with high-resolution respirometry using the OROBOROS Oxygraph-2k. Both methods will report a variety of mitochondrial parameters resulting in 48 measures per participant, creating robust profiles of bioenergetic health. Additional analysis will include western blots to enumerate protein density for the five major mitochondrial complexes, mtDNA copy number analysis, and citrate synthase activity as these assays provide different but complementary data to respirometry for a more dynamic picture of mitochondrial metabolism.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Christina Cramer, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2021-09-22
Completion
2023-06-09

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939858 on ClinicalTrials.gov