NCT01576289

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

April 11, 2012

Last Update Submit

July 23, 2012

Conditions

Gastroesophageal Reflux DiseaseGastritis

Keywords

EsophagusGastroesophageal refluxReflux esophagitisBarrett's esophagusStomachIntestinal metaplasia stomachHelicobacter pylori infectionProton pump inhibitorDuodenumDuodenal bulbCeliac disease diagnosis

Study Arms (1)

Patients undergoing uppper endoscopy

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

Other: Histological analysis

Interventions

Histological analysisOTHER

Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination

Patients undergoing uppper endoscopy

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who routinely undergo upper endoscopy (for different, not selected reasons)

You may qualify if:

  • none

You may not qualify if:

  • Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Graz, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements.

MeSH Terms

Conditions

Gastroesophageal RefluxGastritisEsophagitis, PepticBarrett Esophagus

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisStomach DiseasesEsophagitisPeptic UlcerDuodenal DiseasesIntestinal DiseasesPrecancerous ConditionsNeoplasms

Study Officials

  • Cord Langner, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Scientist

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 12, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

AU(1)