NCT05709522Completed
Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor
Neurocognitive and Psychosocial Outcomes Among Pediatric Brain Tumor Patients Presenting to a Tertiary Care Hospital of Karachi, Pakistan: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 48 (actual)
- First submitted
- 15 Jun 2021
- Start date
- 20 Nov 2020
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Aga Khan University
- Diseases
- Childhood cancers
- NCT number
- NCT05709522
What you commit to
- Study type: Observational
- Participants enrolled: 48
- From 20 Nov 2020 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children who have received any type of treatment for brain tumor and blood cancer
Other illness
- Children with metastatic brain tumor and blood cancer
- Known cases of any illness leading to psychiatric/neurological illness (e.g. ADHD, autism, schizophrenia) as confirmed by medical records, will be excluded from the study as they may be on medications that might distort the results.
- Children with physical comorbidities and debilitating disease
Other
- Children presenting with recurrence
- Children who will loss to follow-up
- \-
Who the study is looking for
- 5-21 years children with brain tumor, presenting with any stage
- Children residing in Pakistan for at least 3 months.
- Children accompanied by both or either of the parent
- Children with basic understanding of English
- Children and their parents who understand and speak in Urdu
- Children and their parents who will give assent / consent to participate in the study
Age in the registry: 5 years to 21 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nida Zahid Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.