FatigueNCT07365696
Fatigue and Cognitive Dysfunction Due to Synaptopathy or Graft Versus Host (GVH) Disease in the Brain.
An observational study of Fatigue and Graft Vs Host Disease, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Patients undergoing allogenic stem cell transplantation are regularly followed up in the outpatient clinic at Karolinska University Hospital. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Graft Vs Host Disease, Cognitive Dysfunction
- What is being tested?
- PET investigation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 28 Nov 2023to 28 Dec 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergone allogeneic stemcell transplantation
Inclusion Criteria: PET images available retrospectively
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
Ksenia Boriskina
Stockholm, 14186
Ksenia Boriskina, MD, 0812380675, ksenia.boriskina@regionstockholm.se
About this study
Official title: Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan.
Patients undergoing allogenic stem cell transplantation are regularly followed up in the outpatient clinic at Karolinska University Hospital. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Meanwhile liquor samples and advanced PET imaging techniques are available for these patients as part of a research project allowing extensive immunological and radio-morphological studies.
- Conditions
- Fatigue, Graft Vs Host Disease, Cognitive Dysfunction
- Being tested
- PET investigation
- Medical subject headings
- Fatigue, Graft vs Host Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET investigationRadiation
Trial subjects will undergo two advanced PET investigations
| Study group | Role | What they receive |
|---|---|---|
| Patients with fatigue and cognitive dysfunction | Not described Receives: Radiation: PET investigation | |
| Patients without fatigue and cognitive dysfunction | Not described Receives: Radiation: PET investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the role of inflammation on synaptic density and glial cell activation as the cause of mental fatigue and cognitive dysfunction in survivors after alloSCT.
Analysis of PET imaging (both descriptive and radiokinetical) in combination with biological markers for neuroinflammation.
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 posted26 Jan 2026
- Study start28 Nov 2023
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2028 (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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Ksenia Boriskina, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365696
- Sponsor's protocol ID
- 2023-02021-01
- Other IDs
- 2023
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2023
- Last updated
- 26 Jan 2026
- Results posted
- 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 26 Jan 2026. 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
- NCT07365696
- Acronym / sponsor ID
- 2023-02021-01
- Conditions
- Fatigue, Graft Vs Host Disease, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 26 Jan 2026 (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.
Patients undergoing allogenic stem cell transplantation are regularly followed up in the outpatient clinic at Karolinska University Hospital. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Meanwhile liquor samples and advanced PET imaging techniques are available for these patients as part of a research project allowing extensive immunological and radio-morphological studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fatigue and cognitive dysfunction | – | Radiation: PET investigation |
| Patients without fatigue and cognitive dysfunction | – | Radiation: PET investigation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone allogeneic stemcell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET investigationTrial subjects will undergo two advanced PET investigations | Radiation | Patients with fatigue and cognitive dysfunction, Patients without fatigue and cognitive dysfunction |
Primary outcome
To investigate the role of inflammation on synaptic density and glial cell activation as the cause of mental fatigue and cognitive dysfunction in survivors after alloSCT.
Time frame: 2024-2027
Analysis of PET imaging (both descriptive and radiokinetical) in combination with biological markers for neuroinflammation.
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 26 Jan 2026.
- 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 Graft Vs Host Disease, run by Karolinska University Hospital 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?
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 26 Jan 2026. 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?
To investigate the role of inflammation on synaptic density and glial cell activation as the cause of mental fatigue and cognitive dysfunction in survivors after alloSCT. (time frame: 2024-2027). 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 26 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.