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.
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
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).
- Conditions
- Lymphoma, Central Nervous System Lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted28 Dec 2007 (estimated)
- Study startJul 2000
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Denise Correa, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning and Quality of Life in CNS Lymphoma
- ClinicalTrials.gov ID
- NCT00581737
- Acronym / sponsor ID
- 00-083
- Conditions
- Lymphoma, Central Nervous System Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Correa, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
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.