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TerminatedNCT00710151Updated Apr 21, 2017

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

An observational study in Primary Central Nervous System Lymphoma (PCNSL), sponsored by OHSU Knight Cancer Institute. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-21.

Sponsored by OHSU Knight Cancer Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Central Nervous System Lymphoma (PCNSL)

Keywords

  • neurotoxicity
  • cognition in survivors
  • diagnostic imaging
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 80 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)

Groups and cohorts

  • 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, blood brain barrier disruption (BBBD) with chemotherapy, radiation, and stem cell transplantation.

06

What researchers measure

Primary outcomes

  1. Neuropsychological Functioning

    Time frame: More than 2 years after treatment

Secondary outcomes

  1. MRI

    Time frame: More than 2 years after treatment

07

Study locations

4 sites
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Charite University Medicine
    Berlin, Germany
  • University of Bochum
    Bochum, Germany
  • University Medical Center
    Freiburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00710151
Lead sponsor
OHSU Knight Cancer Institute
Collaborators
National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Edward Neuwelt (Professor, OHSU Knight Cancer Institute) — Principal investigator
First posted
Jul 4, 2008
Start date
Jul 2008
Primary completion
Dec 2012
Completion
Dec 2013
Last update
Apr 21, 2017

Study contacts

Edward A Neuwelt, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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