Celiac DiseaseNCT02805816
Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease
An observational study of Celiac Disease, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Celiac Disease
- How many people
- 128 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Jun 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- 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
Who cannot join
- IgA (Immunoglobulin A) deficiency
- Malignancy
- Inflammatory Bowel Disease
- Severe chronic infection (HIV, Tuberculosis)
- Primary immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Small bowel biopsies have so far been considered as the reference standard for the diagnosis of Celiac disease (CD). However, during the last decades evidence has accumulated on the diagnostic value of specific CD antibodies and has increasingly been used for diagnostic purposes. At the same time, the leading role of histology for the diagnosis of CD has been questioned for several reasons: histological findings are not specific for CD, lesions may be patchy and can occur in the duodenal bulb only and interpretation depends on preparation of the tissue and is prone to a high inter-observer variability. The diagnosis of CD may then depend not only on the results of small bowel biopsies, but also on information from clinical data and on results from specific CD antibody testing. ESPGHAN (European Society of Gastroenterology, Hepatology and Nutrition) guidelines for the diagnosis of CD which was recently published enabled diagnosis of CD based on classical symptoms and high titre levels (>10 times upper limit of normal) of tissue transglutaminase (TG2) and positive Endomysial Anti bodies (EMA) in separate blood samples.
Due to these facts, it is important to use serological kit for TG2 with high specificity and sensitivity. The aim of this study is to assess in a prospective study the kit with the highest sensitivity and specificity among patients with suspected CD.
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 (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
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Celiac Disease based on histological findings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start8 Jun 2016
- Primary completionJun 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, raanan shamir, Rabin Medical Center
- Investigators
- Firas Rinawi, MD, Study director, Schneider Children's Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805816
- Sponsor's protocol ID
- 0466-15 RMC
- Status last verified
- Sep 2018
- First submitted
- 8 Jun 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease
- ClinicalTrials.gov ID
- NCT02805816
- Acronym / sponsor ID
- 0466-15 RMC
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Tissue transglutaminase, Histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Small bowel biopsies have so far been considered as the reference standard for the diagnosis of Celiac disease (CD). However, during the last decades evidence has accumulated on the diagnostic value of specific CD antibodies and has increasingly been used for diagnostic purposes. At the same time, the leading role of histology for the diagnosis of CD has been questioned for several reasons: histological findings are not specific for CD, lesions may be patchy and can occur in the duodenal bulb only and interpretation depends on preparation of the tissue and is prone to a high inter-observer variability. The diagnosis of CD may then depend not only on the results of small bowel biopsies, but also on information from clinical data and on results from specific CD antibody testing. ESPGHAN (European Society of Gastroenterology, Hepatology and Nutrition) guidelines for the diagnosis of CD which was recently published enabled diagnosis of CD based on classical symptoms and high titre levels (>10 times upper limit of normal) of tissue transglutaminase (TG2) and positive Endomysial Anti bodies (EMA) in separate blood samples.
Due to these facts, it is important to use serological kit for TG2 with high specificity and sensitivity. The aim of this study is to assess in a prospective study the kit with the highest sensitivity and specificity among patients with suspected CD.
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 (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD according to histological findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- IgA (Immunoglobulin A) deficiency
- Malignancy
- Inflammatory Bowel Disease
- Severe chronic infection (HIV, Tuberculosis)
- Primary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Celiac Disease based on histological findings.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firas Rinawi, MD study director
Schneider Children's Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Celiac Disease based on histological findings. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.