- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127709
A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
February 7, 2024 updated by: Memorial Sloan Kettering Cancer Center
A Clinical, Structural, and Functional Neuroimaging Study of Cognition in Adults With Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, and Other Histiocytoses
The purpose of this study is to try to understand how histopcytosis can cause symptoms or problems in the brain.
The tests being done in the study will look at memory and thinking as well as brain function via MRI scan.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
- Behavioral: Trail Making Test, Parts A & B
- Behavioral: Brief Test of Attention
- Behavioral: Symbol Span
- Behavioral: Controlled Oral Word Association Test
- Behavioral: The Hopkins Verbal Learning Test-Revised
- Behavioral: Brief Visuospatial Memory Test-Revised
- Behavioral: Hospital Anxiety and Depression Scale
- Behavioral: McGill Quality of Life Scale
- Diagnostic test: MR Brain Imaging
- Diagnostic test: Resting state functional MRI
- Behavioral: Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants will have a diagnosis of a histiocytic disorder as determined, in the opinion of the study PI, by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
Description
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Fluency in English
- Diagnosis of a histiocytic disorder as determined, in the opinion of the study PI, by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
- Will undergo Standard of Care MRI.
Exclusion Criteria:
- Known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma)
- Prior stroke or intracranial hemorrhage
- Other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the PI or Co-PI to confound neuroimaging studies (e.g., demyelinating disease)
- Existing diagnosis of a psychiatric disorder or untreated mood disturbance
- Existing diagnosis of a neurodegenerative disease, such as Alzheimer's disease
- Chronic or daily excessive alcohol consumption as determined by the PI.
- History of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past
- History of severe claustrophobia or other contraindications to patient SOC brain MRI
- Prior intravenous cytarabine or cladribine
- Other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the PI or Co-PI to confound imaging studies or cognitive performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants with a histiocytic disorder diagnosis
Participants will have a histiocytic disorder as determined by a corroborating constellation of histopathology, clinical, and/or radiologic findings.
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Part A is a timed measure of visual scanning and graphomotor speed.
Part B is a timed measure of cognitive flexibility.
Assesses auditory working memory
Other Names:
Assesses visual working memory
Other Names:
The COWA timed test of phonemic verbal fluency.
It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S).
Other Names:
HVLT-R is a test of verbal learning and memory.
Scores obtained are the total number of words.
Other Names:
The BVMT-R is a test of visuospatial learning and memory.
Other Names:
The HADS is a brief assessment validated in many cancer populations.
Other Names:
This is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer.
Other Names:
Standard of care brain MR imaging includes high-resolution 3D T1-weighted images in the axial plane.
The axial T1-weighted images will be isotropic with a typical matrix size of 256 x 256, 256 mm field-of-view (FOV) and 1 mm slice thickness covering the whole brain.
Scanning will be performed on a 3 Tesla General Electric scanner (Optima 750W) with a GEM HNU 24-channel head coil.
rsFMRI matching the FLAIR and T1 post-contrast images will be obtained.
For resting state fMRI, T2*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR = 2500 ms, TE = 30 ms, FA = 80°, slice thickness = 4 mm, FOV= 240mm2, matrix=64×64) covering whole brain.
For the resting state fMRI portion of the scan, patients will be instructed by the technologist or research staff to leave eyes open, focus on looking at a crosshair, and not think about anything during the scan.
Other Names:
This is a validated 37-item QOL instrument for cancer patients with cognitive complaints.
The measures consist of FACT-Cog total, perceived cognitive impairments, perceived cognitive abilities, and impact on quality of life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neurocognitive function
Time Frame: 1 year
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Neurocognitive tests will yield raw scores that are converted to z-scores, normalized for participant's age, sex and educational level.The proportion of participants demonstrating cognitive impairment (as defined by 2 or more z-scores less than -1.5) will be summarized.
Also, the proportion of participants with impairment (z < -1.5) for each cognitive test will be summarized.
In this way the cognitive assessment yields a dichotomous outcome of impaired versus not impaired for each participant but also allow for more granular assessment of impairment in specific cognitive domains.
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1 year
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quality of life
Time Frame: 1 year
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questionnaires will yield raw scores (total score for HADS and McGill QOL, as well as anxiety and depression subscores for the HADS).
QOL scores will be analyzed as raw scores.
Cognitive test scores will be transformed into z-sores (based on score distributions from established normative samples with a mean of 0 and standard deviation of 1) to define the presence/severity of cognitive dysfunction.
Scores will be normalized for age, sex and education.
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1 year
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comparing of grey matter volume
Time Frame: 1 year
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In a whole-brain analysis, first, cortical thickness will be compared between participants and controls and regions of statistically significant grey matter loss will be identified.
This is done computionally with a whole-brain, vertex-by-vertex approach, as stated above.
Also, as stated above (Section 7), statistical significance thresholding is at p<0.001, correcting for multiple comparisons using the False Discovery Rate (FDR) method and clustering thresholds, methods used in various high-throughput contexts, including MRI analysis.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eli Diamond, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2017
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
April 11, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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