Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease

NCT02805816 | Completed DMC

• 1 other identifier: 0466-15 RMC
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will perform prospective observational multicenter study which includes children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study group) and children without suspicion of CD who underwent gastroscopy for other reasons. The investigators will compare sensitivity, specificity and predictive values of several serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD according to histological findings.

Conditions

Celiac Disease

Keywords

Celiac disease; Tissue transglutaminase; Histology

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Celiac Disease based on histological findings.

  1 year

Study Arms (2)

Study group

Children with suspicion of CD based on positive serology (TG2 \>2 times upper limit of normal) and classical clinical manifestations or belonging to high risk groups, who underwent gastroscopy with intestinal biopsies.

Control group

Children without suspicion of CD who underwent gastroscopy and duodenal biopsies for other reasons (abdominal pain, failure to thrive, vomiting, eg)

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study group: 100 children with suspicion of CD based on positive serology (TG2 \>2 times upper limit of normal) and classical clinical manifestations or belonging to high risk groups, who underwent gastroscopy with intestinal biopsies. Control group: 100 children without suspicion of CD who underwent gastroscopy for other reasons (abdominal pain, failure to thrive, vomiting, eg)

You may qualify if:

• Child with clinical suspicion of CD (chronic or recurrent diarrhea, Failure to thrive, growth impairment , iron deficiency anemia, vomiting, chronic abdominal pain, abdominal distension , constipation, fatigue, recurrent oral aphthous or dermatitis herpetiformis) and high TG2 serology (\>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies Or
• Asymptomatic child who belongs to high risk group of celiac (Diabetes mellitus type 1, Hashimoto thyroiditis, Down syndrome, Turner syndrome, Williams syndrome, Auto-immune Hepatitis or first degree with CD) and high TG2 serology (\>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies .
• and
• signed consent form

You may not qualify if:

• IgA (Immunoglobulin A) deficiency
• Malignancy
• Inflammatory Bowel Disease
• Severe chronic infection (HIV, Tuberculosis)
• Primary immunodeficiency

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider children's medical center of Israel

Petah Tikva, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10 cc of blood samples (for celiac serology kits assessment)

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Firas Rinawi, MD

  Schneider Children's Medical Center, Israel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 20, 2016
• Study Start: June 8, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

IL (1)