Expired Study
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Portland, Oregon 97239


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

IRB00003805


NCT ID:

NCT00710151


Secondary ID:

R01NS033618


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

OHSU Knight Cancer Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

80


Enrollment Type:

Actual


Overall Contact Information

Official Name:Edward A Neuwelt, MD
Principal Investigator
Oregon Health and Science University

Study Dates

Start Date:July 2008
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 19, 2017
First Received Date:July 2, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:MRI
Time Frame:More than 2 years after treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Neuropsychological Functioning
Time Frame:More than 2 years after treatment
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:OHSU Knight Cancer Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Samples and Retentions

Study Population: Individuals who have had PCNSL and have survived disease-free for 2 years or more.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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