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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05709522
Other study ID # 2021-4859-18168.
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 20, 2020
Est. completion date November 30, 2023

Study information

Verified date January 2023
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 and blood cancer 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.


Description:

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Study Design


Intervention

Behavioral:
Neurocognitive tools
Neurocognitve and psychological tools

Locations

Country Name City State
Pakistan Nida Zahid Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Aga Khan University Jinnah Postgraduate Medical Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuro-cognitive outcomes The Verbal component of neurocognition will be assessed by slosson scale.A higher score means a better outcome November 2020 to November 2023
Primary Neuro-cognitive outcomes The non verbal component of neurocognition will be assessed by Raven tool (non verbal) a higher score means good neurocognition November 2020 to November 2023
Primary Neuro-cognitive outcomes The non verbal component i.,e processing speed of neurocognition will be assessed by Wechler scale . A high score means good neurocognition November 2020 to November 2023
Primary Quality of life of child Pediatric Quality of Life Inventory tools ( generic, brain module and cancer module); Score 0-100; higher scores means good Quality of life November 2020 to November 2023
Primary Depression and anxiety Revised Children's Anxiety and Depression Scale and hospital anxiety and depression scale; score 0-141 a higher score mean high depression and anxiety; 0-7 mild depression and anxiety; 8=10 moderate depression and anxiety and 11-21 severe depression and anxiety November 2020 to November 2023
Secondary Parents health related Quality of life Pediatric Quality of Life™ Family Impact Module will be used to assess parents quality of life ; a higher score means a good Quality of life November 2020 to November 2023
Secondary MicroRNA serum micro RNA (mi-21, mi-10b and mi-210) and will be assessed by qRT-PCR November 2020 to November 2023
Secondary S100 calcium-binding protein B (S100ß) protein markers S100ß will be assessed by ELISA November 2020 to November 2023
Secondary Neurons and peripheral neuroendocrine cells (NSE) protein markers NSE will be assessed by ELISA November 2020 to November 2023
Secondary Glial fibrillary acidic protein (GFAP) protein markers GFAP will be assessed by ELISA November 2020 to November 2023
Secondary financial burden of the disease on the family; visual analog scale ranging from no burden (0) to very large burden (100). high score and means higher burden of the disease November 2020 to November 2023
Secondary Care giver Reaction scale Caregiver Reaction Assessment (CRA) tool ) The questionnaire consists of 24 items measuring five subscales: impact on disrupted schedule, financial problems, lack of family support, health problems and impact on self-esteem. Caregivers have to indicate their level of agreement using a 5-point Likert-type Scale ranging from 1 (strongly disagree) to 5 (strongly agree). For each subscale, a score is calculated by taking the average of the items. Higher scores indicate a greater impact (either beneficial or detrimental). November 2020 to November 2023
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