An interventional study of Digestive endoscopy in Esophagitis, Eosinophilic, sponsored by Fondation Lenval. Not yet recruiting at 1 site in France. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Fondation Lenval · Not applicable, Interventional, and Other
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The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months.
This study would also enable us to investigate the quality of life of these chronically ill patients
The investigator would like to create a prospective cohort of 16 patients included over 2 years in order to determine the rate of complete remission (clinical, endoscopic and histological) at 3 months, 6 months, 12 months, 18 months and 24 months of treatment initiation. It is also planned to describe this cohort of pediatric EO patients at inclusion and throughout follow-up, and to study their quality of life.
Follow-up visits is organized every 3 months with a gastropediatrician, who assesses the patient's symptoms (PEESS score) and quality of life (PedsQL eosinophilic esophagitis module and PedsQL 4.0 Generic Core Scales).
If treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 16 is below the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Fondation Lenval is the lead sponsor of 61 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Follow-up visits are always organized in the same way. A consultation with a gastropediatrician will take place, with assessment of symptoms (PEESS score) and quality of life (PedsQL module for eosinophilic esophagitis and PedsQL 4.0 Generic Core Scales). Then, if treatment needs to be introduced or changed, a digestive endoscopy with biopsies will be carried out at 3 months to determine whether the patient is in remission or not. Depending on the results, the patient may be advised to adapt or maintain the current treatment.
Other: Digestive endoscopy
Digestive endoscopies are performed in the operative room under general anaesthetic 3 months after the introduction or change of treatment. Biopsies of the upper, middle and lower thirds of the esophagus will be taken and analyzed for pathology.
Determine the rate of complete remission
Complete remission will be defined according to the following criteria: 1. Abolition of clinical symptoms as assessed by the Pediatric Eosinophilic Esophagitis Symptom Score 2. Endoscopic score: EoE Endoscopic Reference Score (EREFS) ≤ 2 in the lower, middle and upper thirds of the esophagus. 3. Eosinophilic infiltrate \< 5/HPF in standard HES (Haemato-Eosin-Safran) stain on biopsies from lower, middle and upper thirds of esophagus 4. No therapeutic change at follow-up visit to assess remission
Time frame: at 3 months, 6 months, 12 months, 18 months and 24 months from treatment initiation.
Description at inclusion of a cohort of pediatric patients with OE
The description of the population will be carried out at baseline and during a 24 months follow-up at each consultation (M3, M6, M12, M18 and M24) by the patient's referring physician, listing : * demographic (age, gender, lifestyle) and medical (history, allergies, etc.) data at baseline only * Clinical data (types of symptoms, possible complications, etc.) * Paraclinical data (endoscopic and anapathic scores at diagnosis)
Time frame: throught a 24 months follow-up
evolution of quality of life
Quality of life will be measured using the Pediatric Quality of Life Questionnaire (PedsQL Eosinophilic Esophagitis part ) currently being validated in French by our team. The PedsQL eosinophilic eosophagitis module is divided into several forms, each corresponding to different age groups with questions adapted according to age. (2-4 years, 5-7 years, 8-12 years and 13-18 years). This questionnaire is intended for children and their parents. The total score is the sum of the 35 items for 8-17 year olds, 22 for 2-4 year olds, 27 for 5-7 year olds. The maximum score is 175 for 8-17 year olds, 110 for 2-4 year olds, 135 for 5-7 year olds. The higher the score, the greater the impact of eosinophilic esophagitis on the patient's life. Nevertheless, we will also use a more general quality-of-life questionnaire, the PedsQL 4.0 Generic Core Scales in its French version.
Time frame: at diagnosis, 3 months, 6 months, 12 months, 18 months and 24 months of treatment
Start is estimated for Mar 2024; primary completion for Mar 2028, 48 months later.
Of 23 interventional studies with no phase under Eosinophilic Esophagitis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Fondation Lenval