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Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE) (EoE)
| Condition or disease |
|---|
| Eosinophilic Esophagitis |
Participants with a diagnosis of EoE are recruited from Rady Children's Hospital Eosinophilic Gastrointestinal Disorders (EGID) during routine clinic and/or endoscopy visits.
Medical information including clinical symptoms, endoscopy, histopathology, medical and surgical history, lab and imaging findings, are entered into a UCSD database at each clinic or endoscopy visit. Blood and biopsy specimens are procured and utilized for analysis of inflammatory molecules and for isolation of structural cells. This protocol continues our clinical database and sample collection in children with EoE. The database provides a cohort of EoE patients for studies of natural history, therapeutic response, and disease progression. In a relatively new disease of increasing incidence, these studies will provide information on disease progression and the clinical characteristics of patients who have varying disease phenotypes as well as the associations between clinical phenotypes, molecular changes, and disease course. The procurement and storage of tissue, cells, and serum samples provides a repository for studies of EoE-related molecules and peripheral markers in clinically phenotyped patients. In addition, the study of these esophageal cells will provide an in vitro model system for assessing the molecular mechanisms of disease pathogenesis in EoE.
| Study Type : | Observational |
| Estimated Enrollment : | 1200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE) |
| Actual Study Start Date : | February 11, 2019 |
| Estimated Primary Completion Date : | December 17, 2028 |
| Estimated Study Completion Date : | December 17, 2028 |
- The longitudinal trajectory of symptoms, endoscopy, and histology in pediatric EoE during routine clinical care [ Time Frame: 10 years ]Outcome measures of symptoms, histology, endoscopy, and lab values such as peripheral eosinophilia and cortisol procured at each clinical and/or endoscopy visit will be entered and tracked in a UCSD/RCHSD de-identified database in order to understand their longitudinal trajectory during routine clinical care
- The longitudinal trajectory of inflammatory markers in blood and biopsies in pediatric EoE during routine clinical care [ Time Frame: 10 years ]The presence and severity of inflammatory markers and cells over time in specimens collected during routine endoscopy and biopsy will be measured to understand their alignment with outcome measures of symptoms, histology, and endoscopy
Biospecimen Retention: Samples With DNA
| Ages Eligible for Study: | 1 Year to 65 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Have a known EoE diagnosis
- Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)
- Present with food impaction
- Present with esophageal stricture
- Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings
Exclusion Criteria:
- None
| Contact: Kira Chaiboonma, BS | 8589661700 ext 226884 | kchaiboonma@health.ucsd.edu | |
| Contact: Seema S Aceves, MD, PhD | 8585342983 | saceves@ucsd.edu |
| United States, California | |
| Rady Children's Hospital San Diego | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Kira Chaiboonma, BS 858-966-1700 ext 226884 kchaiboonma@health.ucsd.edu | |
| Contact: Seema Aceves, MD,PhD 8589665961 saceves@ucsd.edu | |
| Principal Investigator: Seema Aceves, MD.PhD | |
| Sub-Investigator: Ranjan Dohil, MD | |
| Sub-Investigator: Robert Newbury, MD | |
| Sub-Investigator: Cathleen Collins, MD | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 23, 2019 | ||||||||
| First Posted Date | June 10, 2019 | ||||||||
| Last Update Posted Date | March 4, 2021 | ||||||||
| Actual Study Start Date | February 11, 2019 | ||||||||
| Estimated Primary Completion Date | December 17, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE) | ||||||||
| Official Title | Characteristics and Inflammatory Markers in Children With Eosinophilic Esophagitis (EoE) | ||||||||
| Brief Summary | Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers | ||||||||
| Detailed Description |
Participants with a diagnosis of EoE are recruited from Rady Children's Hospital Eosinophilic Gastrointestinal Disorders (EGID) during routine clinic and/or endoscopy visits. Medical information including clinical symptoms, endoscopy, histopathology, medical and surgical history, lab and imaging findings, are entered into a UCSD database at each clinic or endoscopy visit. Blood and biopsy specimens are procured and utilized for analysis of inflammatory molecules and for isolation of structural cells. This protocol continues our clinical database and sample collection in children with EoE. The database provides a cohort of EoE patients for studies of natural history, therapeutic response, and disease progression. In a relatively new disease of increasing incidence, these studies will provide information on disease progression and the clinical characteristics of patients who have varying disease phenotypes as well as the associations between clinical phenotypes, molecular changes, and disease course. The procurement and storage of tissue, cells, and serum samples provides a repository for studies of EoE-related molecules and peripheral markers in clinically phenotyped patients. In addition, the study of these esophageal cells will provide an in vitro model system for assessing the molecular mechanisms of disease pathogenesis in EoE. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Esophageal biopsies and/or cells derived from biopsies and Blood
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The majority of patients who are diagnosed with EoE or suspected EoE at RCHSD/UCSD | ||||||||
| Condition | Eosinophilic Esophagitis | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 17, 2028 | ||||||||
| Estimated Primary Completion Date | December 17, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 1 Year to 65 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03980886 | ||||||||
| Other Study ID Numbers | 181690 1K24AI135034-01 ( U.S. NIH Grant/Contract ) 5R01AI092135-07 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Seema Aceves, University of California, San Diego | ||||||||
| Study Sponsor | University of California, San Diego | ||||||||
| Collaborators |
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| Investigators | Not Provided | ||||||||
| PRS Account | University of California, San Diego | ||||||||
| Verification Date | March 2021 | ||||||||
