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

NCT07140445 | Not Yet Recruiting

• 1 other identifier: MindMe
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Intelligence quotient

  Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.

  Day 1

• verbal reasoning

  Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.

  Day 1

• verbal learning

  Assessed by a neuropsychologist using Test of Memory and Learning, second edition (TOMAL--2) and Rey Complex Figure Test and Recognition Trial (RCFT). TOMAL-2 scores are age-based scaled scores; higher scores reflect better verbal memory performance. Scores for RCFT range from 0-36 with higher scores reflecting better visual memory.

  Day 1

• non-verbal reasoning

  Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.

  Day 1

• working memory

  Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.

  Day 1

• executive functioning

  Assessed by a neuropsychologist using Delis-Kaplan Executive Function System (D-KEFS) trailmaking test and verbal fluency test. D-KEFS subtests yield age-based scaled scores. Higher scores indicate better executive functioning.

  Day 1

• sustained attention

  Assessed by a neuropsychologist using Conners' Continuous Performance Test 3rd Edition (CPT-3). The test evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance. Scaled scores (t-scores) range from 0-100, higher = better performance.

  Day 1

• processing speed

  Scored on the clinical neurocognitive tests Wechler Intelligence Scale for Children Fifth edition (WISC-V ) for participants 7-16.9 years of age and Wechler Adult Intelligence Scale Fourth edition (WAIS-IV) for participants 17 years of age or older. Scaled scores range from 0-19, higher = better performance.

  Day 1

• fine motor skills

  Assessed by a neuropsychologist using Delis-Kaplan Executive Function System (D-KEFS) trailmaking test. D-KEFS subtests yield age-based scaled scores. Higher score indicates better fine motor skills

  Day 1

Secondary Outcomes (20)

• Waist circumference

  Day 1

• Triglycerides

  Day 1

• HDL-cholesterol

  Day 1

• Fasting glucose

  Day 1

• Blood pressure

  Day 1

Other Outcomes (22)

• Hepatic fat and NAFDL stage

  Day 1

• Body composition: Fat mass

  Day 1

• Body composition: Fat free mass

  Day 1

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants: All survivors of paediatric HSCT in Denmark who have undergone transplantation since 2010, being at least 2 years after HSCT, and at least 7 years of age on the day of assessment are eligible. All participants must be able to speak and understand Danish as well as to understand the research project, to give informed consent to participate. For participants younger than 18 years, where the parents will give consent, at least one parent must speak Danish. Thus, the inclusion criteria are: at least 7 years of age, treatment with HSCT in Denmark since 2010 before the age of 18 years, and ability to speak and understand Danish. Exclusion criteria: Participants who were diagnosed with infantile autism before their HSCT or have Downs Syndrome will be excluded from the study.

You may qualify if:

• =/\> 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.

You may not qualify if:

• diagnosed with infantile autism before their HSCT
• Downs Syndrome

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Child Cancer Foundation: collaborator
• Danish Cancer Society: collaborator
• Danish Cancer Research Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

A buccal swap, plasma, serum and PBMC's will be biobanked

MeSH Terms

Conditions

Cognition Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hilde H Uhlving, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilde H Uhlving, MD, PhD

CONTACT

+45 35451356; hilde.hylland.uhlving@regionh.dk

Nanna Eriksen, MD

CONTACT

+45 30275694; nanna.eriksen.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

DK (1)