NCT01572974

Brief Summary

To Compare the overall quality of life of patients with no Barrett's esophagus , non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease (GERD) symptoms to those with no GERD symptoms

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

6.7 years

First QC Date

April 4, 2012

Last Update Submit

January 16, 2018

Conditions

Barrett's EsophagusGastroesophageal Reflux Disease

Keywords

Barrett's esophagusGastroesophageal reflux diseaseQuality of life

Outcome Measures

Primary Outcomes (1)

  • Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method

    questionnaire

    1 year

Secondary Outcomes (3)

  • SF-36 physical function (PF) subscale

    12 months

  • SF-36 role limitations-physical (RP) subscale

    12 months

  • SF-36 general health (GH) subscale

    12 months

Study Arms (4)

No Barrett's esophagus

Subject without columnar lined esophagus

Nondysplastic BE

Subject with columnar lined esophagus and absence of dysplasia

Low grade dysplastic BE

subject with columnar lined esophagus and presence of low grade dysplasia

High grade dysplastic BE

subject with columnar lined esophagus and presence of high grade dysplasia

Eligibility Criteria

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

The study population is a Veteran population presenting to a VA Hospital with GERD symptom or Barrett's esophagus

You may qualify if:

  • Age 18 or above
  • At least one of the following:
  • Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (7)

  • Gerson LB, Ullah N, Hastie T, Triadafilopoulos G, Goldstein M. Patient-derived health state utilities for gastroesophageal reflux disease. Am J Gastroenterol. 2005 Mar;100(3):524-33. doi: 10.1111/j.1572-0241.2005.40588.x.

    PMID: 15743346BACKGROUND

  • Crockett SD, Lippmann QK, Dellon ES, Shaheen NJ. Health-related quality of life in patients with Barrett's esophagus: a systematic review. Clin Gastroenterol Hepatol. 2009 Jun;7(6):613-23. doi: 10.1016/j.cgh.2009.02.024. Epub 2009 Mar 10.

    PMID: 19281858BACKGROUND

  • Eloubeidi MA, Provenzale D. Health-related quality of life and severity of symptoms in patients with Barrett's esophagus and gastroesophageal reflux disease patients without Barrett's esophagus. Am J Gastroenterol. 2000 Aug;95(8):1881-7. doi: 10.1111/j.1572-0241.2000.02235.x.

    PMID: 10950030BACKGROUND

  • Shaheen NJ, Green B, Medapalli RK, Mitchell KL, Wei JT, Schmitz SM, West LM, Brown A, Noble M, Sultan S, Provenzale D. The perception of cancer risk in patients with prevalent Barrett's esophagus enrolled in an endoscopic surveillance program. Gastroenterology. 2005 Aug;129(2):429-36. doi: 10.1016/j.gastro.2005.05.055.

    PMID: 16083700BACKGROUND

  • Kruijshaar ME, Siersema PD, Janssens AC, Kerkhof M, Steyerberg EW, Essink-Bot ML; CYBAR Study Group. Patients with Barrett's esophagus perceive their risk of developing esophageal adenocarcinoma as low. Gastrointest Endosc. 2007 Jan;65(1):26-30. doi: 10.1016/j.gie.2006.05.030.

    PMID: 17185076BACKGROUND

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND

  • Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, Lind T, Meyer-Sabellek W, Malfertheiner P, Stolte M, Willich SN. Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease-- an analysis based on the ProGERD initiative. Aliment Pharmacol Ther. 2003 Oct 15;18(8):767-76. doi: 10.1046/j.1365-2036.2003.01770.x.

    PMID: 14535869BACKGROUND

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Prateek Sharma, MD

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2016

Study Completion

December 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)