Clinical Trial: A Study of Memory, Thinking, and Brain Imaging in Adults With Histiocytosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Clinical, Structural, and Functional Neuroimaging Study of Cognition in Adults With Erdheim-Chester Disease, Langerhans Cell Histiocytosis, Rosai-Dorfman Disease, and Ot
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.
Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
- 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.
- 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.
- 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 thre
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: April 11, 2017
Date Started: April 7, 2017
Date Completion: April 2020
Last Updated: April 20, 2017
Last Verified: April 2017