Biomarkers for Noninvasive respiratory support in Immunocompromised Children (BioNIC)
C
Courtney Rowan, MD
Primary Investigator
Enrolling By Invitation
1-26 years
All
Phase
N/A
50 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The goal of this study is to identify and validate response to therapy biomarkers for NIV respiratory support in children with ICCs. The central hypothesis is that response-to-therapy biomarkers can identify those most likely to benefit from intervention with NIV. The rationale is that the response-to-therapy biomarkers can allow us to develop a future biomarker-based enrichment strategy for NIV benefit versus early intubation in children with ICC.
The goal of this study is to identify and validate response to therapy biomarkers for NIV respiratory support in children with ICCs. The central hypothesis is that response-to-therapy biomarkers can identify those most likely to benefit from intervention with NIV. The rationale is that the response-to-therapy biomarkers can allow us to develop a future biomarker-based enrichment strategy for NIV benefit versus early intubation in children with ICC.
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?
- Planned blood collection will occur within 24 hours of moderate respiratory support.
- Additional blood will be collected 48 (±24hr) hours after the first sample, and if the patient gets intubated ≥24 hours after the second sample.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Immunocompromised condition, ICC, solid tumor malignancy, hematopoietic cell transplant, CAR- T cell therapy, Riley
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Age: Between 1 Years - 26 Years
-
Gender: All
Inclusion Criteria
1) Age ≤ 26 years old
2) Have a immunocompromising condition (ICC) defined as the following:
• receiving treatment for a hematologic or solid tumor malignancy,
• those post solid organ or hematopoietic cell transplant,
• those who have received CAR- T cell therapy,
• primary or acquired immunodeficiencies,
• taking immunosuppression (high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory)
3) Receiving respiratory support of ≥4 L per minute of supplemental oxygen, high flow nasal cannula, noninvasive positive pressure ventilation and/or invasive mechanical ventilation
4) Clinical plan for venipuncture for clinically indicated labs or has an existing invasive blood drawing access line (central venous catheter, arterial catheter, or blood- drawing IV)
Exclusion Criteria
1) Chronic respiratory support for any reason other than obstructive sleep apnea
2) Weight < 5kg
1) Age ≤ 26 years old
2) Have a immunocompromising condition (ICC) defined as the following:
• receiving treatment for a hematologic or solid tumor malignancy,
• those post solid organ or hematopoietic cell transplant,
• those who have received CAR- T cell therapy,
• primary or acquired immunodeficiencies,
• taking immunosuppression (high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory)
3) Receiving respiratory support of ≥4 L per minute of supplemental oxygen, high flow nasal cannula, noninvasive positive pressure ventilation and/or invasive mechanical ventilation
4) Clinical plan for venipuncture for clinically indicated labs or has an existing invasive blood drawing access line (central venous catheter, arterial catheter, or blood- drawing IV)
Exclusion Criteria
1) Chronic respiratory support for any reason other than obstructive sleep apnea
2) Weight < 5kg
Updated on
26 Nov 2024.
Study ID: PICU-IIR-BIONIC, 22298
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