- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03939858
Recruitment Status Recruiting
First Posted May 7, 2019
Last update posted August 27, 2020
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.
Primary Objective: • To determine the feasibility of performing bioenergetic profiling in glioblastoma patients receiving chemoradiation by ascertaining the proportion of patients who have enough white blood cells in a 16 mL blood to successfully perform the profiling assays. Secondary Objectives: • To determine if either pre-radiotherapy bioenergetic profile or the change in bioenergetic profile from pre-radiotherapy to post-radiotherapy are predictive of subacute cognitive decline after radiation. OUTLINE: Patients undergo neurocognitive testing over 1 hour using a customized battery of tests designed for brain tumor patients at Wake Forest Baptist Comprehensive Cancer Center. Patients also undergo blood collection at baseline and at 1 and 3 months post radiotherapy.
|: Cognitive Function Analysis
Cognitive function will be evaluated using a customized cognitive battery designed for brain tumor patients. 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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
• High grade glioma patients > 18 years old receiving 6 weeks of chemoradiation with a
Karnofsky Performance Status greater than or equal to 50.
- Prior diagnosis (by a physician or neuropsychologist) of any type of dementia (AD,
frontotemporal dementia, vascular dementia, Lewy-body dementia, Parkinson's dementia),
normal pressure hydrocephalus, Creutzfeldt Jacob disease, posterior cortical atrophy,
Huntington's disease, or Korsakoff syndrome will be excluded. Patients who were
diagnosed with Mild Cognitive (MCI) Impairment greater than or equal to 1 year prior
to diagnosis with their high grade glioma will also be excluded. Patients reported by
family members as having memory problems or with subjective memory complaints are
- Patients taking medications known to have a mitotoxic effect (see attached appendix).
Patients who take any of the as needed medications on the list more than 4 times per
week will be excluded. There are medications that are considered mitotoxic that are
not included on this list because of the essential nature of the medications to this
population (steroids, anti-seizure medications, diabetic medications etc.) or high
frequency of use in this population (statins, beta blockers).
- Patients on medications with the potential to enhance cognition including donepezil,
memantine, armodafinil or methylphenidate.
- Patients who are not fluent in English will be excluded.
- Patients with aphasia or other neurologic deficit which would prevent participating in
cognitive testing will be excluded.
- Patients who are unable to fast for 8 hours will be excluded since enrolled patients
will only be able to drink water for the 8 hours before blood draws.
- Patients who drink more than 14 alcoholic drinks per week or with a history of
alcoholism in the last 10 years will be excluded.
- Patients who are active smokers or with a smoking history within the last 5 years will
- Patients with a deficit greater than two (2) standard deviations below normative data
on any given baseline test will be excluded. These patients will be considered screen
failures and will have been consented for the study but will not be registered. Screen
failures and patients who do not complete at least one post-radiotherapy cognitive
testing session will be replaced so that a total of 10 evaluable patients will be
Contact: Ashley Carroll Fansler, RN 336-713-3539 email@example.com
United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center
Wake Forest University Health Sciences
Principal Investigator: Christina Cramer, MD Wake Forest University Health Sciences