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

This study has been terminated.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00710151

First received: July 2, 2008

Last updated: September 25, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2008

Last Updated Date

September 25, 2012

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Neuropsychological Functioning [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00710151 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MRI [ Time Frame: More than 2 years after treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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 MR images as well as examine the contribution of factors such as radiation, age, surgery, chemotherapy etc. to cognition.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Primary Central Nervous System Lymphoma (PCNSL)

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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, BBBD with chemotherapy, radiation, and stem cell transplantation.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT Number ^ICMJE

NCT00710151

Other Study ID Numbers ^ICMJE

OHSU-4093, RO1 NS33618

Has Data Monitoring Committee

Yes

Responsible Party

OHSU Knight Cancer Institute

Study Sponsor ^ICMJE

OHSU Knight Cancer Institute

Collaborators ^ICMJE

National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Edward A Neuwelt, MD

Oregon Health and Science University

Information Provided By

OHSU Knight Cancer Institute

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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