Celiac DiseaseNCT00175760
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
An observational study of Celiac Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Diagnosis of Celiac Disease
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Oct 2006
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Aged 2 months to 18 years with a planned upper GI endoscopy.
Who may be able to join
- Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.
Who cannot join
- Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.
Read the detailed description
All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.
- Conditions
- Celiac Disease
- Being tested
- Diagnosis of Celiac Disease
- Keywords
- TTG, pediatric, comparison study
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of Celiac DiseaseProcedure or surgery
During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionOct 2006
- Study completionOct 2006
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Collin Barker, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175760
- Sponsor's protocol ID
- C04-0304
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.
- ClinicalTrials.gov ID
- NCT00175760
- Acronym / sponsor ID
- C04-0304
- Conditions
- Celiac Disease
- Keywords
- TTG, pediatric, comparison study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Sep 2005 (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.
This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.
Detailed description
All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Aged 2 months to 18 years with a planned upper GI endoscopy.
Key inclusion criteria (1 listed)
- Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.
Key exclusion criteria (1 listed)
- Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of Celiac DiseaseDuring GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 12 Apr 2011.
Related trials for Celiac Disease
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
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.
Dr. Collin Barker principal investigator
University of British Columbia
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 University of British Columbia at 1 site in Canada.
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 1 inclusion and 1 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 12 Apr 2011. 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 Canada. 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.
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 12 Apr 2011.