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Life sciences · Observational Study
ClinicalTrials.gov · October 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05709522). This is a study registration, not published results. Lead sponsor: Aga Khan University. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 48 participants (ACTUAL). Conditions: Brain Tumor, Pediatric. Interventions: BEHAVIORAL: Neurocognitive tools. Primary outcome measures: Neuro-cognitive outcomes , November 2020 to November 2023; Neuro-cognitive outcomes , November 2020 to November 2023; Neuro-cognitive outcomes , November 2020 to November 2023; Quality of life of child , November 2020 to November 2023; Depression and anxiety , November 2020 to November 2023. Brief summary: This will be the first in-depth study to evaluate pretreatment and 12 months post-treatment, neurocognitive and psychological outcomes of children with brain tumor in Pakistan. The investigators will also determine the socioeconomic burden of pediatric brain tumors in low middle-income region and the association of micro RNA and protein markers with neurocognitive outcomes in PBT and blood cancer children. A prospective cohort study with a follow-up of 12 months at the Aga Khan University Hospital, Karachi, Pakistan and Jinnah postgraduate Medical Centre , Karachi, Pakistan will be conducted. After taking consent/ assent the investigators will recruit 80, 5-21 years old children with newly diagnosed brain tumors presenting with any stage, who have not undergone any treatment. Trained psychologist will assess the neurocognitive outcomes by the Slosson scale, Raven's progressive matrices and Wechsler Intelligence Scale for children (WISC V) and Wechsler Adult Intelligence Scale (WAIS-IV) tools. The Quality of life and depression of the children will be determined by PedQL and Revised Children's Anxiety and Depression Scale (RCADS) and hospital anxiety and depression scale (HADs) respectively . The financial burden of the disease on the family will be measured on a visual analog scale ranging from no burden (0) to very large burden (100) and the parents QoL and disrupted schedule, financial problems, lack of family support, health problems and the impact of caregiving on caregiver's self-esteem will be assessed by Pediatric Quality of Life Inventory PedQl (family module) and Caregiver Reaction Assessment (CRA) tools respectively. The serum micro RNA (mi-21, mi-10b and mi-210) and protein markers (GFAP, NSE and S100β) will be assessed by qRT-PCR and ELISA.