Barrett's EsophagusNCT01572974
Quality of Life in Barrett's Esophagus and Gastro-Esophageal Reflux Disease
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Midwest Biomedical Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Gastroesophageal Reflux Disease
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is a Veteran population presenting to a VA Hospital with GERD symptom or Barrett's esophagus
Who may be able to join
- Age 18 or above
- At least one of the following:
- Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City VA Medical Center
Kansas City, Missouri, 64128
About this study
Official title: Quality of Life in Barrett's Esophagus and GERD:GERD Symptoms, Perception of Cancer Risk, and Actual Cancer Risk
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
Read the detailed description
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
- Keywords
- Barrett's esophagus, Gastroesophageal reflux disease, Quality of life
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method
questionnaire
Measured: 1 year
Secondary outcomes (3)
SF-36 physical function (PF) subscale
questionnaire
Measured: 12 months
SF-36 role limitations-physical (RP) subscale
questionnaire
Measured: 12 months
SF-36 general health (GH) subscale
questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionSep 2016
- Study completionDec 2017
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Responsible party
- Principal investigator, PRATEEK SHARMA, Midwest Biomedical Research
- Investigators
- Prateek Sharma, MD, Principal investigator, Kansas City VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572974
- Sponsor's protocol ID
- PS0056
- Status last verified
- Jan 2018
- First submitted
- 4 Apr 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15743346Crockett 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.
PubMed 19281858Eloubeidi 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.
PubMed 10950030Shaheen 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.
PubMed 16083700Kruijshaar 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.
PubMed 17185076Ware 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.
PubMed 1593914Kulig 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.
PubMed 14535869
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Barrett's Esophagus and GERD:GERD Symptoms, Perception of Cancer Risk, and Actual Cancer Risk
- ClinicalTrials.gov ID
- NCT01572974
- Acronym / sponsor ID
- PS0056
- Keywords
- Barrett's esophagus, Gastroesophageal reflux disease, Quality of life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Study start
- Jan 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a Veteran population presenting to a VA Hospital with GERD symptom or Barrett's esophagus
Key inclusion criteria (3 listed)
- Age 18 or above
- Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method
Time frame: 1 year
questionnaire
3 secondary outcomes
SF-36 physical function (PF) subscale
Time frame: 12 months
SF-36 role limitations-physical (RP) subscale
Time frame: 12 months
SF-36 general health (GH) subscale
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Background: PubMed 15743346Gerson 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.
- Background: PubMed 19281858Crockett 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.
- Background: PubMed 10950030Eloubeidi 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.
- Background: PubMed 16083700Shaheen 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.
- Background: PubMed 17185076Kruijshaar 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.
- Background: PubMed 1593914Ware 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.
- Background: PubMed 14535869Kulig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prateek Sharma, MD principal investigator
Kansas City VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Gastroesophageal Reflux Disease, run by Midwest Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572974, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.