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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00710151
Enrollment
80
Registered
2008-07-04
Start date
2008-07-31
Completion date
2013-12-31
Last updated
2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Keywords

neurotoxicity, cognition in survivors, diagnostic imaging

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
OHSU Knight Cancer Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Neuropsychological FunctioningMore than 2 years after treatment

Secondary

MeasureTime frame
MRIMore than 2 years after treatment

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026