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

Terminated

• Conditions: Primary Central Nervous System Lymphoma (PCNSL)

• Registration Number: NCT00710151
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-04
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropsychological Functioning	More than 2 years after treatment

Secondary Outcome Measures

Name	Time	Method
MRI	More than 2 years after treatment

Trial Locations

Locations (4)

Charite University Medicine; 🇩🇪 Berlin, Germany

University Medical Center; 🇩🇪 Freiburg, Germany

University of Bochum; 🇩🇪 Bochum, Germany

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States