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

April 19, 2017 updated by: Edward Neuwelt, OHSU Knight Cancer Institute

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.

Study Overview

Status

Terminated

Conditions

Primary Central Nervous System Lymphoma (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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany
    - Charité University Medicine
  - Bochum, Germany
    - University of Bochum
  - Freiburg, Germany
    - University Medical Center
United States
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropsychological Functioning Time Frame: More than 2 years after treatment	More than 2 years after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
MRI Time Frame: More than 2 years after treatment	More than 2 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

National Institutes of Health (NIH)

Investigators

Principal Investigator: Edward A Neuwelt, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria