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

NCT00710151 | Terminated DMC

• 3 other identifiers: IRB00003805R01NS033618OHSU-3805
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 4

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.

Conditions

Primary Central Nervous System Lymphoma (PCNSL)

Keywords

neurotoxicity; cognition in survivors; diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Functioning

  More than 2 years after treatment

Secondary Outcomes (1)

• MRI

  More than 2 years after treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Charite University Medicine

Berlin, Germany

Location

University of Bochum

Bochum, Germany

Location

University Medical Center

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Edward A Neuwelt, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

US (1); DE (3)