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

This study has been terminated.
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Edward Neuwelt, OHSU Knight Cancer Institute Identifier:
First received: July 2, 2008
Last updated: April 19, 2017
Last verified: April 2017
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 Type: Observational
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

Resource links provided by NLM:

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Neuropsychological Functioning [ Time Frame: More than 2 years after treatment ]

Secondary Outcome Measures:
  • MRI [ Time Frame: More than 2 years after treatment ]

Enrollment: 80
Study Start Date: July 2008
Study Completion Date: December 2013
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, blood brain barrier disruption (BBBD) with chemotherapy, radiation, and stem cell transplantation.

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who have had PCNSL and have survived disease-free for 2 years or more.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00710151

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Charite University Medicine
Berlin, Germany
University of Bochum
Bochum, Germany
University Medical Center
Freiburg, Germany
Sponsors and Collaborators
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
  More Information

Responsible Party: Edward Neuwelt, Professor, OHSU Knight Cancer Institute Identifier: NCT00710151     History of Changes
Obsolete Identifiers: NCT00706472
Other Study ID Numbers: IRB00003805
R01NS033618 ( US NIH Grant/Contract Award Number )
OHSU-3805 ( Other Identifier: OHSU IRB )
Study First Received: July 2, 2008
Last Updated: April 19, 2017

Keywords provided by OHSU Knight Cancer Institute:
cognition in survivors
diagnostic imaging

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Chemically-Induced Disorders processed this record on May 23, 2017