Monitoring Neurocognitive Dysfunction and the Impact of Metabolism and Physical Capacity After Paediatric HSCT

NCT ID: NCT07140445

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-03-01

Brief Summary

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Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as reduced muscle mass, cardiovascular disease and diabetes.

Some survivors of bone marrow transplantation in childhood also seem to experience changes in cognitive functions. These changes may be experienced as difficulties with concentration, forgetfulness, learning difficulties, and challenges in school or the labour market. Currently, the extent of cognitive changes following bone marrow transplantation in childhood is not fully understood, nor how it relates to other late effects, and what can be done to prevent cognitive impairment.

This research project will examine cognitive function in a group of survivors of bone marrow transplantation in childhood and find out whether there is a correlation between reduced cognitive function and the occurrence of other late effects, including metabolic changes and reduced physical capacity. It will also explore associations between cognitive function at late follow up and blood-based biomarkers of neurological damage and systemic inflammation at the time of transplantation to identify predictors of reduced cognitive function.

The goal of the study is to evaluate the level of cognitive functioning after bone marrow transplantation in childhood, see how it relates to other late effect and identify risk factors and biomarkers in the blood that can predict which patients are at risk of neurocognitive impairment. The results of this study will hopefully contribute to optimizing the prevention and treatment of cognitive impairments following bone marrow transplantation in childhood, thereby improving the quality of life for survivors of bone marrow transplantation in childhood.

Detailed Description

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Conditions

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Stem Cell Transplant Late Effect Neurocognitive Dysfunction Paediatric Patients Metabolic Syndrome Physical Capacity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* =/\> 7 years of age
* treatment with HSCT in Denmark since 2010
* treatment with HSCT was before the age of 18 years
* ability to speak and understand Danish.

Exclusion Criteria

* diagnosed with infantile autism before their HSCT
* Downs Syndrome
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Child Cancer Foundation

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Danish Cancer Research Foundation

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Hilde Hylland Uhlving

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilde H Uhlving, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Hilde H Uhlving, MD, PhD

Role: CONTACT

+45 35451356

Nanna Eriksen, MD

Role: CONTACT

+45 30275694

Facility Contacts

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Hilde H Uhlving, MD, PhD

Role: primary

+45 35451356

Nanna Eriksen, MD

Role: backup

+45 30275694

Other Identifiers

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MindMe

Identifier Type: -

Identifier Source: org_study_id

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