Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 7:45 PM
Ignite Modification Date: 2025-12-24 @ 7:45 PM
NCT ID: NCT06123403
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.
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.
Study: NCT06123403
Study Brief:
Protocol Section: NCT06123403