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LymphomaNCT00581737

Cognitive Functioning and Quality of Life in CNS Lymphoma

An observational study of Lymphoma and Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate several aspects of thinking abilities including attention and memory, and quality of life in patients who were diagnosed with and treated for Primary CNS Lymphoma (PCNSL), and are in remission of their disease. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lymphoma, Central Nervous System Lymphoma
How many people
50 participants
Where
1 siteUnited States
Study dates
Jul 2000to Aug 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Primary Care Clinic

Who may be able to join

  • Diagnosis of and treatment for PCNSL
  • Disease in remission at the time of testing, as defined by negative MRI and/or CSF cytology, and ocular exam if initially positive
  • English speaking

Who cannot join

  • patients who are medically unstable
  • patients with severe, decompensated psychiatric disorders
  • patients with a pre-existing neurological condition other than the designated illness (e. g., head trauma)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

The purpose of this study is to evaluate several aspects of thinking abilities including attention and memory, and quality of life in patients who were diagnosed with and treated for Primary CNS Lymphoma (PCNSL), and are in remission of their disease. The findings of this study may help us understand whether this disease and its treatment may have affected some patients' thinking skills, and may provide important information that can be used to develop programs to improve the quality of life of patients with PCNSL.

This research will also study whether persons having particular types of genes involved in the metabolism of methionine (5-methyltetrahydrofolate-homocysteine S-methyltransferase-MTR, MTFH reductase-MTFHR, transcobalamin 2-Tc2), and apolipoprotein E (APOE) are more likely to have delayed adverse effects after treatment for their tumors. The findings of this study may help us understand whether this disease and its treatment may have affected some patients' thinking skills, and whether this may be related to having certain genes.

Read the detailed description

The incidence of primary central nervous system lymphoma (PCNSL) has increased threefold in immunocompetent populations in recent years. Improvements in treatment, particularly involving combined modality therapy with chemotherapy and radiotherapy have been shown to augment patient survival with a median disease-free period of about 40 months. However, the combination of these two modalities often increases the risk for delayed neurotoxicity. There is a paucity of studies that have assessed neuropsychological functioning and quality of life in patients with PCNSL. The majority of studies reported performance status and survival rates, but systematic cognitive evaluations were only seldom included. Unfortunately, relying only on these variables does not adequately assess the more subtle cognitive impairments that most patients with brain tumors experience. Neuropsychological difficulties often interfere with disease free patients' ability to function at premorbid levels at work and at home. A study including neuropsychological evaluations of a relatively large group of patients with PCNSL who received combined modality treatments, and are in remission from their disease is planned. A follow-up assessment also will be performed in order to monitor performance over a specified period of time. The proposed study will also test the hypotheses that: (1) the presence of polymorphisms that influence methionine metabolism places PCNSL patients treated with chemotherapy alone or in combination with radiotherapy at risk for developing treatment-induced white matter disease and cognitive dysfunction; (2) the possession of the apolipoprotein E (APOE) є-4 allele is associated with the development of cognitive difficulties following treatment for PCNSL. Research in order to better understand the incidence, extent, and severity of treatment-induced neuropsychological impairments in patients with PCNSL is of utmost importance, given the recent increase in both the number of cases diagnosed and longterm survival. It is likely to provide valuable information regarding specific cognitive domains that should be addressed in the development of strategies for cognitive rehabilitation or other interventions that may be appropriate. The findings of this study will also be relevant for comparison with ongoing and future research investigating the potential neurocognitive sequelae of alternative treatment modalities for PCNSL (e.g., high-dose chemotherapy followed by peripheral blood progenitor cell (PBPC) transplant).

Medical subject headings
Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The goal of this study is to examine the neurobehavioral functioning of PCNSL survivors who received radiation and chemotherapy treatments, and are in remission from their disease.

    Measured: 2 years

Secondary outcomes (1)
  1. Examine the delayed effects of whole-brain radiation and chemotherapy on several aspects of cognitive functioning, and quality of life. Also, perform a follow-up evaluation in order to monitor neurocognitive functioning over a specified period of time.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2007 (estimated)
  2. Study startJul 2000
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00581737
Sponsor's protocol ID
00-083
Status last verified
Mar 2012
First submitted
21 Dec 2007
Last updated
5 Mar 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma and Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The goal of this study is to examine the neurobehavioral functioning of PCNSL survivors who received radiation and chemotherapy treatments, and are in remission from their disease. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.

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