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A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127709
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Histiocytosis 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)

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical, Structural, and Functional Neuroimaging Study of Cognition in Adults With Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, and Other Histiocytoses
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022


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.
Behavioral: Trail Making Test, Parts A & B
Part A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility.

Behavioral: Brief Test of Attention
Assesses auditory working memory
Other Name: BTA

Behavioral: Symbol Span
Assesses visual working memory
Other Name: WMS-IV

Behavioral: Controlled Oral Word Association Test
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 Name: COWA

Behavioral: The Hopkins Verbal Learning Test-Revised
HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
Other Name: HVLT-R

Behavioral: Brief Visuospatial Memory Test-Revised
The BVMT-R is a test of visuospatial learning and memory.
Other Name: BVMT-R

Behavioral: Hospital Anxiety and Depression Scale
The HADS is a brief assessment validated in many cancer populations.
Other Name: HADS

Behavioral: McGill Quality of Life Scale
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 Name: McGill QOL

Diagnostic Test: MR Brain Imaging
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.

Diagnostic Test: Resting state functional MRI
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 Name: rsFMRI

Behavioral: Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
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.




Primary Outcome Measures :
  1. neurocognitive function [ Time Frame: 1 year ]
    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.

  2. quality of life [ Time Frame: 1 year ]
    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.

  3. comparing of grey matter volume [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127709


Contacts
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Contact: Eli Diamond, MD 212-610-0243 diamone1@mskcc.org
Contact: Denise Correa, PhD 212-610-0491

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Eli Diamond, MD    212-610-0243      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Eli Diamond, MD    212-610-0243      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Eli Diamond, MD    212-610-0243      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Eli Diamond, MD    212-610-0243      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Eli Diamond, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03127709    
Other Study ID Numbers: 17-199
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
17-199
histiocytosis
Additional relevant MeSH terms:
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Histiocytosis
Lymphatic Diseases