Gastroesophageal Reflux DiseasehistoGERDNCT01576289
Analysis of Biopsies From the Upper Gastrointestinal Tract
An observational study of Gastroesophageal Reflux Disease and Gastritis, run by Medical University of Graz at 1 site in Austria.
Trial summary
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Gastritis
- What is being tested?
- Histological analysis
- How many people
- 600 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to May 2012
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who routinely undergo upper endoscopy (for different, not selected reasons)
Who may be able to join
- none
Who cannot join
- Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.
Read the detailed description
Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.
The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.
Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.
- Conditions
- Gastroesophageal Reflux Disease, Gastritis
- Being tested
- Histological analysis
- Keywords
- Esophagus, Gastroesophageal reflux, Reflux esophagitis, Barrett's esophagus, Stomach, Intestinal metaplasia stomach, Helicobacter pylori infection, Proton pump inhibitor, Duodenum, Duodenal bulb, Celiac disease diagnosis
- Medical subject headings
- Gastroesophageal Reflux, Gastritis, Esophagitis, Peptic, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histological analysisOther
Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing uppper endoscopy | Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012. Receives: Other: Histological analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cord Langner, MD, Medical University of Graz
- Investigators
- Cord Langner, MD, Principal investigator, Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576289
- Sponsor's protocol ID
- Reflux_Multicenter_1
- Acronym
- histoGERD
- Status last verified
- Jul 2012
- First submitted
- 11 Apr 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)
- ClinicalTrials.gov ID
- NCT01576289
- Acronym / sponsor ID
- histoGERD / Reflux_Multicenter_1
- Conditions
- Gastroesophageal Reflux Disease, Gastritis
- Keywords
- Esophagus, Gastroesophageal reflux, Reflux esophagitis, Barrett's esophagus, Stomach, Intestinal metaplasia stomach, Helicobacter pylori infection, Proton pump inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Apr 2012 (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.
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.
Detailed description
Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.
The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.
Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing uppper endoscopy | – | Other: Histological analysisConsecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who routinely undergo upper endoscopy (for different, not selected reasons)
Key inclusion criteria (1 listed)
- none
Key exclusion criteria (1 listed)
- Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
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 |
|---|---|---|
| Histological analysisSystematic histological analysis of biopsy specimens obtained during routine endoscopic examination | Other | Patients undergoing uppper endoscopy |
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 24 Jul 2012.
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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.
Cord Langner, MD principal investigator
Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria
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 Gastroesophageal Reflux Disease and Gastritis, run by Medical University of Graz at 1 site in Austria.
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 24 Jul 2012. 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 Austria. 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 24 Jul 2012.