Cerebral Morbidity After Radiation Therapy for Brain Tumors

NCT04292353 | Unknown

• 1 other identifier: WP-12
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 4

Brief Summary

This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.

Conditions

Brain Tumor; Cognitive Impairment; Radiation Toxicity

Keywords

Brain tumor; Cognitive function; Radiation Therapy; Hippocampus

Outcome Measures

Primary Outcomes (1)

• Impairment of memory as assessed by the HVLT-r test

  Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)

  5 Years

Secondary Outcomes (10)

• Processing speed

  5 Years

• Attention and working memory

  5 Years

• Verbal learning and memory

  5 Years

• Verbal fluency

  5 Years

• Executive function

  5 Years

Interventions

Cognitive tests and Patient Reported Outcome OTHER

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be diagnosed with a primary brain tumour and referred to radiation therapy. They will be recruited from the four neuro oncology centers in Denmark

You may qualify if:

• years or older and Danish speaking.
• Performance status WHO 0-2
• Capable of cooperating on testing
• Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

You may not qualify if:

• Glioblastoma
• Performance status 3-4

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (4)

Rigshospital

Copenhagen, Region H, 2100, Denmark

Location

Department of Oncology

Aarhus, Region Midt, 8000, Denmark

Location

Aalborg University Hospital

Aalborg, Region Nord, 9000, Denmark

Location

Odense University Hospital

Odense, Region Syd, 5000, Denmark

Location

MeSH Terms

Conditions

Brain Neoplasms; Cognitive Dysfunction; Radiation Injuries

Interventions

Neuropsychological Tests; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Morten Høyer, M.D

  Danish Center for Particel Therapy, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: March 3, 2020
• Study Start: July 1, 2016
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)