NCT00955019

Brief Summary

This study is being done to see how biomarkers (abnormalities in molecules of cells ) present in their Barrett's esophagus agree with results from surveillance biopsies; and to compare three different brush devices used to collect cells to see which of these 3 brush devices obtains a higher number of cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

August 5, 2009

Last Update Submit

September 14, 2009

Conditions

Barrett Esophagus

Keywords

Barrett'sEsophagusRefluxdysplasiaadenocarcinoma

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with barretts esophagus

You may qualify if:

  • Patient age greater than 18 years of age
  • Prior histological demonstration of Barretts Esophagus that is endoscopically visible with no dysplasia
  • Low grade, high grade dysplasia or early esophageal cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cytology specimens

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal RefluxAdenocarcinoma

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

US(1)