Correlation of Ammonia Levels for Diagnosis of Veno-Occlusive Disease (VOD)
M
Mahvish Rahim
Primary Investigator
Administratively Closed
1 years - 3 years
All
Phase
N/A
54 participants needed
1 Location
Brief description of study
What is the purpose of this study?
Assessing the correlation of ammonia level at the time of VOD diagnosis and throughout the course of the VOD Diagnosis.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
• We will ask about the subject's medical history, including past and present medication use.
• The study team will collect information about the subject from their medical records and use it for this study.
• The subject will have a blood test to check the levels of ammonia in their blood weekly as part of their standard transplant treatment. The blood will be drawn through the subject's port or central line when they are already getting blood taken for standard of care. The weekly blood draw will be continued until discharge from the hospital if the subject is never suspected and/or discharged with VOD. Once the subject is discharged from the hospital, their participation in the study will end.
• If the subject is suspected and/or diagnosed with the liver problem (VOD) during their stay in the hospital, they will have blood drawn 3 times per week through their port or central line along with standard of care bloodwork until their liver problem resolves. Hospitalization is required until VOD is resolved per standard of care, so the blood draws and study participation will continue until their VOD resolves in the hospital.
• The study team will collect information about the subject from their medical records and use it for this study.
• The subject will have a blood test to check the levels of ammonia in their blood weekly as part of their standard transplant treatment. The blood will be drawn through the subject's port or central line when they are already getting blood taken for standard of care. The weekly blood draw will be continued until discharge from the hospital if the subject is never suspected and/or discharged with VOD. Once the subject is discharged from the hospital, their participation in the study will end.
• If the subject is suspected and/or diagnosed with the liver problem (VOD) during their stay in the hospital, they will have blood drawn 3 times per week through their port or central line along with standard of care bloodwork until their liver problem resolves. Hospitalization is required until VOD is resolved per standard of care, so the blood draws and study participation will continue until their VOD resolves in the hospital.
Around 1 teaspoon or 3mLs of blood will be taken at each time point for a total of around 20 teaspoons or 60 mLs.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Veno-Occlusive Disease, Riley
-
Age: 1 years - 3 years
-
Gender: All
Inclusion Criteria:
- Pediatric patients (1-30yo) undergoing allogeneic or autologous (limited to High Risk Neuroblastoma and Brain Tumor patients) HSCT
Exclusion Criteria:
- Patients with hyperammonemia at baseline
Updated on
12 Nov 2024.
Study ID: 2001008515, PEDS-CC-IUSCC-0728, PHO-IIR-IUSCC-0728
