NCT07365696

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
31mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2023Dec 2028

First Submitted

Initial submission to the registry

November 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2028

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

November 27, 2023

Last Update Submit

January 19, 2026

Conditions

FatigueGraft Vs Host DiseaseCognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    2024-2027

Study Arms (2)

Patients with fatigue and cognitive dysfunction

Radiation: PET investigation

Patients without fatigue and cognitive dysfunction

Radiation: PET investigation

Interventions

PET investigationRADIATION

Trial subjects will undergo two advanced PET investigations

Patients with fatigue and cognitive dysfunctionPatients without fatigue and cognitive dysfunction

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergone allogeneic stemcell transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ksenia Boriskina

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

FatigueGraft vs Host DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsImmune System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 27, 2023

First Posted

January 26, 2026

Study Start

November 28, 2023

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)