Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors

This study has been terminated.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00710151
First received: July 2, 2008
Last updated: September 25, 2012
Last verified: September 2012

July 2, 2008
September 25, 2012
July 2008
December 2012   (final data collection date for primary outcome measure)
Neuropsychological Functioning [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00710151 on ClinicalTrials.gov Archive Site
MRI [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Neurotoxicity in Primary Central Nervous System Lymphoma (PCNSL): An International Observational Study of Cognition in Long Term Survivors
Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Individuals who have had PCNSL and have survived disease-free for 2 years or more.

Primary Central Nervous System Lymphoma (PCNSL)
Not Provided
1
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00710151
OHSU-4093, RO1 NS33618
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
  • National Institutes of Health (NIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Edward A Neuwelt, MD Oregon Health and Science University
OHSU Knight Cancer Institute
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP