FatigueNCT06363396
Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study
An observational study of Fatigue and Cognitive Dysfunction, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Fatigue, Cognitive Dysfunction
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 22 Feb 2024to 22 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20-75, both male and female who are 1-5 years after allogeneic stem cell transplantation.
Who may be able to join
- status 1-5 years after HSCT
- no known CNS disorders or psychiatric disturbances
Who cannot join
- prior TBI or CNS irradiation / intrathecal therapy
- known neurological or psychiatric disorder
- time less then 1 year or over 5 years after transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska
Stockholm, 14186
Ksenia Boriskina, MD, 0858580675, ksenia.boriskina@regionstockholm.se
Kirsti Niemelä, study nurse
About this study
Official title: Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan
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 and/or 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 [ 11C]PBR28 as well as the SV2A radioligand [ 11C]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties.
Read the 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 hypothesis.Investigators 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 Alzheimer's 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.
- Conditions
- Fatigue, Cognitive Dysfunction
- Medical subject headings
- Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fatigue and cognitive dysfunction | Patients that are one to five years after allogeneic stem cell transplantation and have signs of fatigue and cognitive dysfunction measured by international standarts. | |
| Patients without fatigue and cognitive dysfunction | Patients that are one to five years after allogeneic stem cell transplantation and have no detectable signs of fatigue and cognitive dysfunction measured by international standarts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of cognitive tests
Measured by CANTAB and Geras panels
Measured: 2024-2027
Potential biomarkers for fatigue and cognitive dysfunction
Measured in blood and csf by using mass spectrometry-based proteomics approaches and Olink technology by selecting different panels of proteins based on data available in the literature.
Measured: 2024-2027
PET results
The primary analysis will focus on the frontal cortex.
Measured: 2024-2027
Secondary outcomes (1)
Global analyses of the neural connections
Global analyses of the neural connections have recently been suggested as potentially important biomarkers of neurocognitive dysfunction after aHSCT
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start22 Feb 2024
- Primary completion22 Feb 2026 (estimated)
- Study completion22 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Ksenia Boriskina, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363396
- Sponsor's protocol ID
- K 2023-7081
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan
- ClinicalTrials.gov ID
- NCT06363396
- Acronym / sponsor ID
- K 2023-7081
- Conditions
- Fatigue, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Feb 2026 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 12 Apr 2024 (actual)
- 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.
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 and/or 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 [ 11C]PBR28 as well as the SV2A radioligand [ 11C]UCB-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 hypothesis.Investigators 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 Alzheimer's 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fatigue and cognitive dysfunction | – | –Patients that are one to five years after allogeneic stem cell transplantation and have signs of fatigue and cognitive dysfunction measured by international standarts. |
| Patients without fatigue and cognitive dysfunction | – | –Patients that are one to five years after allogeneic stem cell transplantation and have no detectable signs of fatigue and cognitive dysfunction measured by international standarts. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20-75, both male and female who are 1-5 years after allogeneic stem cell transplantation.
Key inclusion criteria (2 listed)
- status 1-5 years after HSCT
- no known CNS disorders or psychiatric disturbances
Key exclusion criteria (3 listed)
- prior TBI or CNS irradiation / intrathecal therapy
- known neurological or psychiatric disorder
- time less then 1 year or over 5 years after transplantation
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
Results of cognitive tests
Time frame: 2024-2027
Measured by CANTAB and Geras panels
Potential biomarkers for fatigue and cognitive dysfunction
Time frame: 2024-2027
Measured in blood and csf by using mass spectrometry-based proteomics approaches and Olink technology by selecting different panels of proteins based on data available in the literature.
PET results
Time frame: 2024-2027
The primary analysis will focus on the frontal cortex.
1 secondary outcome
Global analyses of the neural connections
Time frame: 2024-2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
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 Fatigue and Cognitive Dysfunction, run by Karolinska Institutet at 1 site in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 12 Apr 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of cognitive tests (time frame: 2024-2027). The study lists 3 primary outcomes in all. 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 12 Apr 2024.