Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363396
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-20
Brief Title:
Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation Prospective PET Study
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host GVH Sjukdom i hjärnan
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic Here patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment A larger well-defined patient cohort is necessary to confirm these results Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction andor fatigue This will be performed with two methods
by using mass spectrometry-based proteomics approaches
Olink technology
PET examinations will be performed on both fatigued and non-fatigued We will utilize the second generation TSPO radioligand 11CPBR28 as well as the SV2A radioligand 11CUCB-J both showing high signal-to-noise ratio and adequate test-retest properties
by using mass spectrometry-based proteomics approaches
Olink technology
PET examinations will be performed on both fatigued and non-fatigued We will utilize the second generation TSPO radioligand 11CPBR28 as well as the SV2A radioligand 11CUCB-J both showing high signal-to-noise ratio and adequate test-retest properties
Detailed Description:
Investigators plan to enroll 30 patients Blood and liquor samples will be processed frozen and stored in biobanks In addition to the clinical tests we will analyze a large set of proinflammatory cytokines and performed and advanced immunophenotyping to determine the exact signature of immune cells in the blood and and in the liquor The clinical data after will be systematically analyzed in an uni- and multivariate fashion for underlying risk factors medications and outcome This unique set of high quality clinical data together with the results from the lab and the radioimaging will provide a unique data set allowing to answer the research questions associated with the underlying hypothesisInvestigators plan to validate previous findings in a larger cohort and test whether neurocognitive testing battery can predict who will develop fatigue and cognitive dysfunction CD We evaluate patients using the Mental Fatigue Scale Fatigue Severity Scale and Cambridge Neuropsychological Test Automated Battery CANTAB as previously described by our group Investigators will implement other test batteries such as GERAS and evaluate relevance for transplanted patients Study aims to obtain novel insights into the pathophysiology of fatigue and CD enabling accurate diagnosis and quantification of the severity Findings may also be important for other long-term survivors after cancer The study is expected to generate knowledge on the interaction between immune and synaptic functions which is relevant both for CNS disorders such as MS and Alzheimers disease but also hematologic malignancies It ensures the safety of individuals undergoing therapy while successful resolution of complications contributes to the long-term efficacy promoting sustained health improvement CANTAB might be directly implemented in the clinic as a tool to evaluate the need for sick-leave and the ability to return to work Advanced imaging techniques will hopefully become a part of clinical praxis facilitating the development of targeted interventions
All patients will perform blood sampling lumbal puncture cognitive tests and neuroimaging with PET and MRI
All patients will perform blood sampling lumbal puncture cognitive tests and neuroimaging with PET and MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None