Quality of Life in Barrett's Esophagus and Gastro-Esophageal Reflux Disease

NCT ID: NCT01572974

Last Updated: 2018-01-18

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

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Recruitment Status

TERMINATED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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The presence of GERD symptoms is associated with a significant decrease in quality of life.While a diagnosis of Barrett's esophagus is also associated with a decrease in quality of life, these studies evaluated Barrett's esophagus patients with GERD symptoms.It is unclear whether decrements in quality of life from cancer risk in patients with Barrett's esophagus are due to actual cancer risk or a patient's false perception.Here we 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). The Investigators will 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. Finally the investigators will compare the overall quality of life of patients with a perceived low risk of esophageal cancer to those with a perceived high risk of esophageal cancer

Conditions

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Barrett's Esophagus Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No Barrett's esophagus

Subject without columnar lined esophagus

No interventions assigned to this group

Nondysplastic BE

Subject with columnar lined esophagus and absence of dysplasia

No interventions assigned to this group

Low grade dysplastic BE

subject with columnar lined esophagus and presence of low grade dysplasia

No interventions assigned to this group

High grade dysplastic BE

subject with columnar lined esophagus and presence of high grade dysplasia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Age 18 or above

At least one of the following:

Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kansas City Veteran Affairs Medical Center

FED

Sponsor Role collaborator

Midwest Biomedical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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PRATEEK SHARMA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prateek Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City VA Medical Center

Locations

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Kansas City VA Medical Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15743346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19281858 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10950030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16083700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17185076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1593914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14535869 (View on PubMed)

Other Identifiers

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PS0056

Identifier Type: -

Identifier Source: org_study_id

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