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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06227962
Other study ID # NL82126.029.22
Secondary ID SKOCA 2009020Uit
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 26, 2023
Est. completion date March 31, 2028

Study information

Verified date January 2024
Source Amsterdam UMC, location VUmc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective crosssectional observational study of the effects of oncological treatment and frequent general anesthesia on neuropsychological development, psychosocial functioning (in terms of anxiety, depression, peer relations, perceived cognitive functioning and potential trauma) and health related quality of life in children and young adults who were treated or screened for retinoblastoma.


Description:

Retinoblastoma (Rb) is the most common form of ocular cancer in children, with high survival rates in developed countries (>90%). Rb can develop unilateral (one eye affected, sometimes hereditary), or bilateral (both eyes, always hereditary). Children are usually diagnosed at a young age (<5 years) and are subjected to an intensive treatment and follow-up protocol immediately after. If Rb is diagnosed in early disease stages, eye-saving treatment could be provided, such as laser, cryo-, chemotherapy and/or radiotherapy -or a combination of these. When discovered in a later disease stage, enucleation (removing the eye) is often inevitable. Brothers and sisters or offspring of heredity Rb survivors that are at risk to develop Rb themselves (so called 'Rb risk carriers') will be screened according to the Dutch Rb Screening Protocol. The medical treatment and follow-up of Rb patients and screening of Rb risk carriers takes place under general anesthesia (GA) up to four or five years of age. At this age the brain is still developing and therefore extra vulnerable to iatrogenic damage, including neuropsychological complications. Immediate effects of the oncological treatment, as well as secondary effects due to multiple GA on cognitive development in Rb survivors is still understudied. Rb survivors report disease-related limitations in daily life and lower health related quality of life (HRQoL), which might be related to impaired cognitive functioning. Apart from possible immediate or secondary treatment effects, children with Rb are known to be experiencing psychosocial struggles, including anxiety and depression, declined participation and/or pediatric trauma, which may negatively affect HRQoL as well. Despite the impact on general wellbeing and HRQoL, the cognitive and emotional aspects of Rb are largely under addressed in pediatric care. It is important to gain insight in the cognitive development and psychosocial functioning from childhood into young adulthood of Rb survivors, as well psychosocial functioning of the parents in order to provide timely interventions, minimizing possible long-term consequences. It is hypothesized that extensive treatment and multiple GA is negatively associated with cognitive functioning, psychosocial functioning and HRQoL in Rb survivors and Rb risk carriers. Moreover, that psychological struggles and/or trauma strengthen these associations.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 660
Est. completion date March 31, 2028
Est. primary completion date March 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 35 Years
Eligibility Inclusion Criteria Rb survivors and Rb risk carriers (age 8-35 years): - Rb diagnosis, (main) treatment and follow-up of Rb patients and -survivors, or Rb screening took place at the Dutch Retinoblastoma Expertise Center of the Amsterdam University Medical Center, - Rb survivor or former Rb risk carriers is between 8 and 35 years old, - Average understanding of the Dutch language. Inclusion Criteria parents of Rb patients, Rb survivors or Rb risk carriers (6 months - 12 years): - Being a caregiver of a Rb survivor or Rb risk carrier that have been diagnosed and receive(d) (main) treatment and follow-up or screening at the Dutch Retinoblastoma Expertise Center of the Amsterdam University Medical Center, - The related Rb survivor or Rb risk carrier is < 12 years old, - Average understanding of the Dutch language. Exclusion Criteria: - Pre-existing documented developmental delay and/or severe cognitive impairments (IQ <70), - Having an active, uncontrolled psychiatric illness, - Rb diagnostic trajectory, treatment and follow-up at another hospital or before the founding of the Dutch Retinoblastoma Expertise Center in 1991. With exception of Rb survivors (diagnosed >1991) who apart from treatment at the Dutch Retinoblastoma Center also required specialized treatment (such as radiation) at another center: they are illegible for inclusion.

Study Design


Intervention

Diagnostic Test:
Neuropsychological assesment
Estimated intelligence (subtasks of Wechsler Intelligence Scale for Children - Fifth edition -Dutch version [WISC-V-NL] or Wechsler Adult Intelligence Scale - Forth edition - Dutch version [WAIS-IV-NL]); Vienna reaction time; Rey auditory verbal learning test; Word fluency; Beery-Buktenica Developmental Test of Visual-Motor Integration, 6th Edition; Test of Everyday Attention for Children (TEA-Ch), subtask Score!/ or Test of Everyday Attention (TEA), subtask Elevator task; Trail making test; Word-color interference test
Psychosocial functioning and quality of life (questionnaires)
Anxiety (PROMIS); Depression (PROMIS); Peer-interaction (PROMIS); Perceived neurocognitive functioning (PROMIS); Participation and activity (PAY-CY); Trauma (KJTS/PCL-5); Health related quality of life (PEDSQL)
Parental psychosocial functioning (questionnaires)
Anxiety (PROMIS); Depression (PROMIS); Distress Thermometer-Parents (DT-P); Trauma (PCL-5)

Locations

Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Amsterdam University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall functioning in Rb General cognitive functioning, psychosocial functioning and health related Quality of life in Rb survivors and Rb risk carriers Through study completion, an average of 3 years
Primary Effects of oncological treatment and frequent anesthesia Effects of biological and physiological factors on cognitive functioning, psychosocial functioning and health related quality of life in Rb survivors and Rb risk carriers Through study completion, an average of 3 years
Primary Parental functioning To assess psychosocial functioning and HRQoL in parents of Rb patients, Rb survivors and Rb risk carriers (0-12 years old). at least 6 months after diagnosis
Secondary Neurocognitive profiles Mapping neuropsychological profiles in Rb survivors and Rb risk carriers (8-35 years) Through study completion, an average of 3 years
Secondary Psychosocial functioning Mapping overall psychosocial functioning in Rb survivors, Rb risk carriers (8-35 years and parents) Through study completion, an average of 3 years
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