Childhood brain Cancer, InSight in Sight; New EXpertise on Tailored ophthalmological follow up in a prospective nationwide study in the Netherlands

*Childhood brain Cancer, InSight in Sight; New EXpertise on Tailored ophthalmological follow up in a prospective nationwide study in the Netherlands* - CCISS Next study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57205

Enrollment

100

Registered

2024-12-27

Start date

2025-06-13

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual decline visual impairment

Interventions

None listed

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Participation in the previous CCISS study (NL67799.041.18) - Indicated during the earlier KIZZ study that it was agreed to approach the patient for follow-up research - Informed and having given informed consent (either by the patient and/or parents/legal guardian)

Exclusion criteria

Exclusion criteria: - Refusal by patiënt and/or parent(s)/legal guardian - If the child has not previously had monitoring as part of the CCISS study

Design outcomes

Primary

Measure	Time frame
The primary outcome measures are visual acuity (logMAR), visual field (results of age-specific visual field test) and changes in OCT parameters (RNFL thickness and GCL-ILP). For further information please refer to the study protocol, chapter 8 (page 18-24).	—

Secondary

Measure	Time frame
Secondary study parameters include measurements of OCT parameters (RNFL thickness and macular GCL-IPL thickness) at baseline and at 4-5 years after diagnosis. Tertiary outcome parameters include baseline characteristics as age, gender, ethnicity, medical (including ophthalmologic) history, neurofibromatosis 1 (yes/no), brain tumor type (histology), tumor location, tumor size and presence/absence of hydrocephalus and/or metastases. The last outcome of this CCISS Next study is the long-term (4-5 years after diagnosis) quality of life in relation to the visual (visual field testing, visual acuity and OCT), medical (type of brain tumor and treatment) and sociodemographic (age, sex) variables. We will assess generic and cancer-specific health-related quality of life (PedsQL), as well as vision-related quality of life (PAI-CY/PAI-YA). For further information please refer to the study protocol, chapter 8 (page 18-24).	—

Measure

Time frame

Secondary study parameters include measurements of OCT parameters (RNFL thickness and macular GCL-IPL thickness) at baseline and at 4-5 years after diagnosis. Tertiary outcome parameters include baseline characteristics as age, gender, ethnicity, medical (including ophthalmologic) history, neurofibromatosis 1 (yes/no), brain tumor type (histology), tumor location, tumor size and presence/absence of hydrocephalus and/or metastases. The last outcome of this CCISS Next study is the long-term (4-5 years after diagnosis) quality of life in relation to the visual (visual field testing, visual acuity and OCT), medical (type of brain tumor and treatment) and sociodemographic (age, sex) variables. We will assess generic and cancer-specific health-related quality of life (PedsQL), as well as vision-related quality of life (PAI-CY/PAI-YA). For further information please refer to the study protocol, chapter 8 (page 18-24).

—

Countries

Netherlands

Outcome results