Investigating Cognitive Impairment in Young Patients With Cancer Prospectively
MyBrain
A Multidisciplinary Neuroscience Approach to Investigate Cognitive Impairment in Young Patients With Cancer Prospectively
1 other identifier
observational
100
1 country
1
Brief Summary
The MyBrain study investigates the brain function of children, adolescents and young adults during and after chemo treatment for cancer. The tests include 1) cognitive skills such as memory and attention; 2) the brain's electrical activity; 3) and biological markers related to brain function. The aim of the study is to better understand the trajectories of cognitive functioning and measures that have been associated with cognitive impairment in patients treated with chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 3, 2023
April 1, 2023
5 years
January 25, 2023
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
T0: within 30 days of diagnosis
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
T2: end of treatment (2 weeks after the final antineoplastic treatment)
Performance on clinical neurocognitive tests: Wechlers scale
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
T3: 6 months after end of treatment
Secondary Outcomes (19)
Trajectories of performance on clinical neurocognitive tests: Grooved Pegboard test
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
Trajectories of performance on clinical neurocognitive tests: Repeatable Battery for the Assessment of Neuropsychological Status
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
Trajectories of performance on clinical neurocognitive tests: Conner's Continuous Performance Test
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
Trajectories of performance on clinical neurocognitive tests: NEPSY-II, A Developmental Neuropsychological Assesment of Neuropsychological Status
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
Trajectories of performance on automated cognitive tests
T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment
- +14 more secondary outcomes
Study Arms (2)
Solid tumor patients
Patients diagnosed with solid tumor cancers
Haematological patients
Patients diagnosed with haematological cancers
Eligibility Criteria
Patients who are diagnosed with a non-central nervous system cancer at Rigshospitalet in Copenhagen, Denmark. The distribution of different cancer diagnoses in the study population will reflect the distribution of non-CNS diagnoses among patients in the age group receiving chemotherapy at the study site. The most common diagnoses are Hodgkin lymphoma, non-Hodgkin lymphoma, testicular cancer, sarcoma, and leukaemia. Approximately 30-40 new patients are expected to be included every year (in total 100 patients during the three-year recruitment period).
You may qualify if:
- Patients who are newly diagnosed with a non-CNS cancer and will undergo chemotherapy at University Hospital Copenhagen, Rigshospitalet.
- At the age of 7-29 years at diagnosis
- Each patient is matched (1:1) with a control participant within 24 months of age. The controls are recruited from the patient's own social circle and can be a friend, partner, or close family (sibling or cousin).
You may not qualify if:
- Unable to speak and understand Danish
- Severe intellectual disability or mental health disorder that hinders participation
- Brain metastases,
- Terminal illness
- Have had a previous chemotherapy or radiotherapy treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Nordhjem BJT, Tjornlund M, Thomsen BL, Hjerming M, Kjaer TW, Pappot H, Hjalgrim LL. Protocol for a prospective, longitudinal study of cognitive impairment in young patients with cancer: a multidisciplinary neuroscience approach (MyBrain). BMJ Open. 2023 May 18;13(5):e070534. doi: 10.1136/bmjopen-2022-070534.
PMID: 37202143DERIVED
Related Links
Biospecimen
Blood, cerebrospinal fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2023
First Posted
May 3, 2023
Study Start
March 1, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
May 3, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share