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

Primary Central Nervous System Lymphoma (PCNSL) Clinical Trial

Official title:

Neurotoxicity in Primary Central Nervous System Lymphoma: An International, Collaborative, Observational Study of Cognition in Long-Term Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00710151
• Other study ID #: IRB00003805
• Secondary ID: R01NS033618OHSU-
• Status: Terminated
• Phase: N/A
• First received: July 2, 2008
• Last updated: April 19, 2017
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00706472

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Neurotoxicity Syndromes
• Primary Central Nervous System Lymphoma (PCNSL)

Locations

Country	Name	City	State
Germany	Charite University Medicine	Berlin
Germany	University of Bochum	Bochum
Germany	University Medical Center	Freiburg
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Functioning		More than 2 years after treatment
Secondary	MRI		More than 2 years after treatment