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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

=/> 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.

Disqualifiers

diagnosed with infantile autism before their HSCT

Downs Syndrome

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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.

Time frame
Day 1
4

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.

Time frame
Day 1

Secondary outcomes

1

Waist circumference

Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

Time frame
Day 1
2

Triglycerides

Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

Time frame
Day 1
3

HDL-cholesterol

Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

Time frame
Day 1
4

Fasting glucose

Blood samples will be drawn from a cannula placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria for Metabolic Syndrome as defined in the 2005 scientific statement (Grundy et al., 2005).

Time frame
Day 1

Other outcomes

1

Hepatic fat and NAFDL stage

Amount of hepatic fat (%), as measured on a MRI scan of the liver with PDFF/liverlab.

Time frame
Day 1
2

Body composition: Fat mass

Body fat mass (%) will be analyzed on a whole-body DEXA scan

Time frame
Day 1
3

Body composition: Fat free mass

Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan

Time frame
Day 1
4

Body composition: Bone mineral density

Bone mineral density, will be analyzed on a whole-body DEXA scan. Z- and T-scores will be calculated.

Time frame
Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Danish Child Cancer Foundation

Collaborator

Danish Cancer Society

Collaborator

Danish Cancer Research Foundation

Collaborator

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