Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors
This research is being done to investigate cognition in long term survivors of Primary Central Nervous System Lymphoma (PCNSL). Sometimes caregivers as well as patients who no longer have the disease report cognitive problems such as reduced memory or attentional dysfunction and decreased quality of life. Unfortunately, little is known about what may contribute to this cognitive dysfunction in part because PCNSL is a rare disease and sensitive tests have not often been used in the research studies. This project is being conducted to help understand what factors, such as radiation, may contribute to cognitive dysfunction and better define the relationship between brain structure and thinking in people who have had PCNSL.
Primary Central Nervous System Lymphoma (PCNSL)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, Observational Study of Cognition in Long-Term Survivors|
- Neuropsychological Functioning [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]
- MRI [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Subjects with PCNSL who have survived disease-free for 2 years or more. Treatments will vary depending upon site of enrollment and will include chemotherapy, BBBD with chemotherapy, radiation, and stem cell transplantation.
This is an international, multi-center project that will enroll as many as 118 subjects of which approximately 35 will be enrolled at OHSU. Neuropsychological testing will consist of a battery of paper and pencil tests that examine abilities such as memory, motor skills, attention and speed of information processing. Questionnaires that assess quality of life will also be administered. These noninvasive tests are administered by a trained examiner or neuropsychologist and last about 30 minutes. Subjects will also undergo an MRI of the head which provides a picture of the brain's structure by placing an individual inside a powerful magnet. Statistical analyses will examine the relationship between the neuropsychological test scores and MR images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710151
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Charite University Medicine|
|University of Bochum|
|University Medical Center|
|Principal Investigator:||Edward A Neuwelt, MD||Oregon Health and Science University|