Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324539
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-15
Brief Title:
Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Validation of a New Innovative Method for the Easy Detection of a Disease Specific Marker to Make Prompt Diagnosis of Celiac Disease in All the Clinical Manifestations a Paediatric Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Celiac disease CD is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals HLA-DQ2DQ8 Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 anti-TG2 and endomysium EMA In symptomatic patients with positive-serum antibodies and villous atrophy the diagnosis of CD is clearcut
However 10-30 of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers a condition identified as potential CD In such cases the diagnosis may remain uncertain
CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease before their appearance in the serum and when the duodenal mucosa is still normal Intestinal CD-antibodies I-CD-abs are a marker of CD have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies EMAbiopsy
The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity However their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories There is an unmet need the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients who may benefit from a therapy based on gluten-free diet and to reduce both unnecessary medical investigations and diagnostic delays
In order to simplify and shorten times for the detection of these intestinal antibodies the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen The obtained samples will be tested with rapid about 15 minutes immune-chromatographic anti-TG2 assay Rapid Intestinal anti-TG2 Assay
However 10-30 of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers a condition identified as potential CD In such cases the diagnosis may remain uncertain
CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease before their appearance in the serum and when the duodenal mucosa is still normal Intestinal CD-antibodies I-CD-abs are a marker of CD have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies EMAbiopsy
The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity However their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories There is an unmet need the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients who may benefit from a therapy based on gluten-free diet and to reduce both unnecessary medical investigations and diagnostic delays
In order to simplify and shorten times for the detection of these intestinal antibodies the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen The obtained samples will be tested with rapid about 15 minutes immune-chromatographic anti-TG2 assay Rapid Intestinal anti-TG2 Assay
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None