Clinical trial NCT00710151: Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors
Official title: Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, Observational Study of Cognition in Long-Term Survivors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Central Nervous System Lymphoma (PCNSL)
Keywords: neurotoxicity
cognition in survivors
diagnostic imaging
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-07-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have had PCNSL and have survived disease-free for 2 years or more.

Brief summary: 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.

Detailed description: This is an international, multi-center project that will enroll as many as 118 subjects of which approximately 35 will be enrolled at Oregon Health \& Science University (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 magnetic resonance (MR) images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition.

Eligibility criteria: Inclusion Criteria:

* Radiological and histological diagnosis of PCNSL
* Age 18 years or older
* Survived 2 years or more following treatment
* Able to complete neuropsychological and neuroimaging parts of the study
* Signed a written informed consent in accordance with institutional guidelines

Exclusion Criteria:

* Subject has experienced recurrent disease
* Subject has a contraindication for MRI
* Subject has a contraindication for neuropsychological testing
* Subject has stage IV or V renal insufficiency

Primary outcomes:
measure: Neuropsychological Functioning
timeFrame: More than 2 years after treatment
Secondary outcomes:
measure: MRI
timeFrame: More than 2 years after treatment
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Berlin
country: Germany
facility: Charite University Medicine
city: Bochum
country: Germany
facility: University of Bochum
city: Freiburg
country: Germany
facility: University Medical Center
Study officials:
affiliation: Oregon Health and Science University
name: Edward A Neuwelt, MD
role: PRINCIPAL_INVESTIGATOR
References: