MedDataX Logo

Analysis of Biopsies From the Upper Gastrointestinal Tract

NCT ID: NCT01576289

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease Gastritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Esophagus Gastroesophageal reflux Reflux esophagitis Barrett's esophagus Stomach Intestinal metaplasia stomach Helicobacter pylori infection Proton pump inhibitor Duodenum Duodenal bulb Celiac disease diagnosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing uppper endoscopy

Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012.

Histological analysis

Intervention Type OTHER

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Histological analysis

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* none

Exclusion Criteria

* Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cord Langner, MD

MD, Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cord Langner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Institute of Pathology, A 8036 Graz, Austria

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Reflux_Multicenter_1

Identifier Type: -

Identifier Source: org_study_id