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NCT06266429 · ClinicalTrials.gov registry record
Metabolomic Profiling of Racial Disparity
A clinical trial of Surgery and Tonsillar Hypertrophy, sponsored by Nationwide Children's Hospital.
- Active
- Registry status
- 84
- Enrollment target
- 1
- Study location
NCT06266429: Active study of Surgery and Tonsillar Hypertrophy, sponsored by Nationwide Children's Hospital.
NCT06266429 is a study of Surgery and Tonsillar Hypertrophy that is active but no longer recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 84 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06266429, a study of Surgery and Tonsillar Hypertrophy, is active but no longer recruiting, sponsored by Nationwide Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain.
Primary Outcome
The global evaluation of small molecule biomarkers, metabolites, and the relative levels of molecular and chemical markers of post-tonsillectomy pain severity. Mass spectrometry detection following separation of protein-precipitated plasma by a C18 column liquid chromatography will provide the relative abundances of small molecule lipids, drug metabolites, amino acids, sugars, and other small potential biomarkers in subjects and using quality-control pooled analysis all samples will be normalize
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood collection
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-03-12 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT06266429 still lists
NCT06266429 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 1 intervention - of which Blood collection is the first listed.
NCT06266429 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06266429 about?
NCT06266429 is a clinical study titled "Metabolomic Profiling of Racial Disparity". Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant pro...
What is the current status of trial NCT06266429?
This trial is currently active not recruiting. The enrollment target is 84 participants. The study started on 2024-03-12. Estimated completion is 2026-12-31.
What conditions does trial NCT06266429 study?
This clinical trial studies the following conditions: Surgery, Tonsillar Hypertrophy, Adenoid Hypertrophy.
What interventions are being tested in trial NCT06266429?
The interventions under investigation include: Blood collection (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06266429?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06266429 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06266429's enrollment target sits among peer trials
84 65th of 120 higher than 56 of 120 other Surgery trials
participants (enrollment target), bucketed by value
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