Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00124956
Eligibility Criteria:
Inclusion Criteria:
* Eligible patients will be \> 1 and ≤ 21 years old.
* All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration \< 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules.
* All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process.
Exclusion Criteria:
* Women who are known to be pregnant or lactating
* Patients with significant uncontrolled systemic illness
* Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) \> 3 times the upper limit of normal tested within 14 days prior to infusion
* Bilirubin \> the upper limit of normal tested within 14 days prior to infusion
* Patients whose dose of doxorubicin is based on ideal body weight
* Patients who weigh \< 12 kilograms at time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00124956
Study Brief:
Protocol Section:
NCT00124956