Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 2:11 AM
Study NCT ID:
NCT06123403
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2023-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of High Dose Methotrexate Toxicity
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Evaluation of High Dose Methotrexate Toxicity in Correlation With Blood Methotrexate Level and the Role of Cystatin C in Prediction of Acute Kidney Injury in Pediatric Malignancies
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to:
1. Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre.
2. Role of methotrexate blood level in prediction of high dose methotrexate related toxicities.
3. Role of Cystatin C as a predictor for acute kidney injury in high dose methotrexate related toxicities.
4. Factors affecting outcome of high dose methotrexate related toxicities.
1. Evaluation of high dose methotrexate related toxicities among children admitted to Sohag Oncology Centre.
2. Role of methotrexate blood level in prediction of high dose methotrexate related toxicities.
3. Role of Cystatin C as a predictor for acute kidney injury in high dose methotrexate related toxicities.
4. Factors affecting outcome of high dose methotrexate related toxicities.
Detailed Description:
It is a prospective observational study will be carried out on children receiving high dose methotrexate in Sohag Oncology Centre with one-year observation starting from January 2024.
All children receiving high dose methotrexate in Sohag Oncology Centre and fulfill the study inclusion criteria with one-year observation starting from January 2024. Informed consent will be taken from the parents/guardians.
A Prepared sheet to collect data related to this study that include:
1. Socio-demographic data: e.g. age, sex, residence in addition to dose of MTX and tumor type.
2. General and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations.
3. Investigations: blood samples will be collected for CBC, Urea, Creatinine, ALT, AST, Methotrexate level and Cystatin C.
4. Treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors.
5. Outcome: complete recovery, residual effects, complications or death.
All children receiving high dose methotrexate in Sohag Oncology Centre and fulfill the study inclusion criteria with one-year observation starting from January 2024. Informed consent will be taken from the parents/guardians.
A Prepared sheet to collect data related to this study that include:
1. Socio-demographic data: e.g. age, sex, residence in addition to dose of MTX and tumor type.
2. General and systemic manifestations: gastrointestinal manifestations, neurological manifestations, respiratory and hematological manifestations.
3. Investigations: blood samples will be collected for CBC, Urea, Creatinine, ALT, AST, Methotrexate level and Cystatin C.
4. Treatment lines: fluid, folinic acid, alkalinization of urine, blood elements, hemodialysis and colony stimulating factors.
5. Outcome: complete recovery, residual effects, complications or death.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: