Barrett's EsophagusNCT02464930
Evaluation of MicroRNA Expression in Blood and Cytology for Detecting Barrett's Esophagus and Associated Neoplasia
An observational study of Barrett's Esophagus and Gastroesophageal Reflux, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus, Gastroesophageal Reflux, Esophageal Adenocarcinoma
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited at the Kansas City VA Hospital and the Mobile Medical unit of the Kansas City VA. The Mobile Medical Unit (MMU) travels to multiple counties to provide health care to the veterans at their doorstep. This is a program that has been in place for several years and continues to grow. Currently, the MMU provides services such as basic health evaluations and phlebotomy to ~600 veterans per week.
Who may be able to join
- Patient age: > 18 years
- Ability to provide written, informed consent
Who cannot join
- Pregnancy or planning a pregnancy
- History of nasal, esophageal \& gastric surgery
- History of recurrent epistaxis or nasal trauma
- Subjects with a history of unresolved drug or alcohol dependency
- Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
- Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
Show all 11Show fewer
- Inability to provide written informed consent
- Inability to discontinue drugs such as Plavix
- Advanced chronic liver disease
- Severe uncontrolled coagulopathy
- Active cancer in any organ over the past 3 years.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
AJAY BANSAL, MD, 816-861-4700 ext. 57790, Ajay.Bansal@va.gov
Andrew Price, AS, 816-861-4700 ext. 56428, Andrew.Price2@va.gov
About this study
Official title: Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.
Read the detailed description
The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.
- Keywords
- Blood, Cytology, Esophagus, microRNA
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Adenocarcinoma Of Esophagus
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-GERD Controls | NERD controls will be enrolled from subjects presenting to the endoscopy unit who are being evaluated for reasons other than GERD or BE surveillance. These are patients who are referred to the endoscopy unit for: evaluation of anemia, dysphagia, occult blood positivity, gastrointestinal blood loss etc. * No history of GERD * Response "no" to presence of symptoms on a standardized GERD questionnaire * No prescriptions for acid suppressive medication over the past 2 years as documented in electronic pharmacy records. * Normal endoscopy that does not find Barrett's esophagus, hiatus hernia or erosive esophagitis. | |
| GERD Controls | * Respond "yes" to the presence of symptoms on a standardized GERD questionnaire * Prescriptions for acid suppressive medication as documented in electronic pharmacy records. | |
| BE Cases | • Patients who present for evaluation of reflux symptoms and are found to have at least 1 cm of columnar lined esophagus on endoscopy with intestinal metaplasia on biopsies. This will include patients with esophageal adenocarcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.
Measured: 1-3 years
Secondary outcomes (1)
Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer
The microRNA expression will be measured by digital polymerase chain reaction
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)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-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center, University of Kansas
- Responsible party
- Principal investigator, Ajay Bansal, Midwest Biomedical Research
- Investigators
- Ajay Bansal, MD, Principal investigator, Veterans Affairs Medical Center and the University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464930
- Sponsor's protocol ID
- AB0009
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
PubMed 23853213Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
PubMed 25162890Rajendra S, Sharma P. Barrett's Esophagus. Curr Treat Options Gastroenterol. 2014 Jun;12(2):169-82. doi: 10.1007/s11938-014-0012-0.
PubMed 24634008Weaver JMJ, Ross-Innes CS, Shannon N, Lynch AG, Forshew T, Barbera M, Murtaza M, Ong CJ, Lao-Sirieix P, Dunning MJ, Smith L, Smith ML, Anderson CL, Carvalho B, O'Donovan M, Underwood TJ, May AP, Grehan N, Hardwick R, Davies J, Oloumi A, Aparicio S, Caldas C, Eldridge MD, Edwards PAW, Rosenfeld N, Tavare S, Fitzgerald RC; OCCAMS consortium. Ordering of mutations in preinvasive disease stages of esophageal carcinogenesis. Nat Genet. 2014 Aug;46(8):837-843. doi: 10.1038/ng.3013. Epub 2014 Jun 22.
PubMed 24952744Hamilton SR, Smith RR, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol. 1988 Aug;19(8):942-8. doi: 10.1016/s0046-8177(88)80010-8.
PubMed 3402983di Pietro M, Alzoubaidi D, Fitzgerald RC. Barrett's esophagus and cancer risk: how research advances can impact clinical practice. Gut Liver. 2014 Jul;8(4):356-70. doi: 10.5009/gnl.2014.8.4.356. Epub 2014 Jul 1.
PubMed 25071900American Gastroenterological Association; Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011 Mar;140(3):1084-91. doi: 10.1053/j.gastro.2011.01.030. No abstract available.
PubMed 21376940Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available.
PubMed 20032324Hur C, Miller M, Kong CY, Dowling EC, Nattinger KJ, Dunn M, Feuer EJ. Trends in esophageal adenocarcinoma incidence and mortality. Cancer. 2013 Mar 15;119(6):1149-58. doi: 10.1002/cncr.27834. Epub 2012 Dec 11.
PubMed 23303625Yousef F, Cardwell C, Cantwell MM, Galway K, Johnston BT, Murray L. The incidence of esophageal cancer and high-grade dysplasia in Barrett's esophagus: a systematic review and meta-analysis. Am J Epidemiol. 2008 Aug 1;168(3):237-49. doi: 10.1093/aje/kwn121. Epub 2008 Jun 12.
PubMed 18550563Hvid-Jensen F, Pedersen L, Drewes AM, Sorensen HT, Funch-Jensen P. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med. 2011 Oct 13;365(15):1375-83. doi: 10.1056/NEJMoa1103042.
PubMed 21995385Reid BJ, Li X, Galipeau PC, Vaughan TL. Barrett's oesophagus and oesophageal adenocarcinoma: time for a new synthesis. Nat Rev Cancer. 2010 Feb;10(2):87-101. doi: 10.1038/nrc2773.
PubMed 20094044Montgomery E, Goldblum JR, Greenson JK, Haber MM, Lamps LW, Lauwers GY, Lazenby AJ, Lewin DN, Robert ME, Washington K, Zahurak ML, Hart J. Dysplasia as a predictive marker for invasive carcinoma in Barrett esophagus: a follow-up study based on 138 cases from a diagnostic variability study. Hum Pathol. 2001 Apr;32(4):379-88. doi: 10.1053/hupa.2001.23511.
PubMed 11331954Shaheen NJ, Hur C. Garlic, silver bullets, and surveillance upper endoscopy for Barrett's esophagus. Gastroenterology. 2013 Aug;145(2):273-6. doi: 10.1053/j.gastro.2013.06.028. Epub 2013 Jun 24. No abstract available.
PubMed 23806540Kadri SR, Lao-Sirieix P, O'Donovan M, Debiram I, Das M, Blazeby JM, Emery J, Boussioutas A, Morris H, Walter FM, Pharoah P, Hardwick RH, Fitzgerald RC. Acceptability and accuracy of a non-endoscopic screening test for Barrett's oesophagus in primary care: cohort study. BMJ. 2010 Sep 10;341:c4372. doi: 10.1136/bmj.c4372.
PubMed 20833740
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MicroRNA Expression in Blood and Cytology Specimens as a Novel Method for Detecting Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT02464930
- Acronym / sponsor ID
- AB0009
- Keywords
- Blood, Cytology, Esophagus, microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center, University of Kansas
- Study start
- Apr 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Jun 2015 (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.
The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.
Detailed description
The investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. The investigators have previously identified BE specific miRNA that will be tested on the cytology specimens. These are miRNAs -192-5p, -215-5p and -194-5p. The investigators have also identified serum microRNAs in whole serum and exosomes by sequencing to study further. The investigators will also evaluate miRNA expression within biliary exosomes for the first time in patients with reflux related diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No-GERD Controls | – | –NERD controls will be enrolled from subjects presenting to the endoscopy unit who are being evaluated for reasons other than GERD or BE surveillance. These are patients who are referred to the endoscopy unit for: evaluation of anemia, dysphagia, occult blood positivity, gastrointestinal blood loss etc. * No history of GERD * Response "no" to presence of symptoms on a standardized GERD questionnaire * No prescriptions for acid suppressive medication over the past 2 years as documented in electronic pharmacy records. * Normal endoscopy that does not find Barrett's esophagus, hiatus hernia or erosive esophagitis. |
| GERD Controls | – | –* Respond "yes" to the presence of symptoms on a standardized GERD questionnaire * Prescriptions for acid suppressive medication as documented in electronic pharmacy records. |
| BE Cases | – | –• Patients who present for evaluation of reflux symptoms and are found to have at least 1 cm of columnar lined esophagus on endoscopy with intestinal metaplasia on biopsies. This will include patients with esophageal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the Kansas City VA Hospital and the Mobile Medical unit of the Kansas City VA. The Mobile Medical Unit (MMU) travels to multiple counties to provide health care to the veterans at their doorstep. This is a program that has been in place for several years and continues to grow. Currently, the MMU provides services such as basic health evaluations and phlebotomy to ~600 veterans per week.
Key inclusion criteria (2 listed)
- Patient age: > 18 years
- Ability to provide written, informed consent
Key exclusion criteria (11 listed)
- Pregnancy or planning a pregnancy
- History of nasal, esophageal \& gastric surgery
- History of recurrent epistaxis or nasal trauma
- Subjects with a history of unresolved drug or alcohol dependency
- Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
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
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia
Time frame: 1-3 years
The two main outcomes are the diagnostic accuracy of tissue and serum microRNA for the the diagnosis of Barrett's esophagus compared to endoscopy.
1 secondary outcome
Differences in the microRNA expression of biliary exosomes between GERD, Barrett's esophagus and Cancer
Time frame: 1-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Background: PubMed 23853213El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
- Background: PubMed 25162890Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
- Background: PubMed 24634008Rajendra S, Sharma P. Barrett's Esophagus. Curr Treat Options Gastroenterol. 2014 Jun;12(2):169-82. doi: 10.1007/s11938-014-0012-0.
- Background: PubMed 24952744Weaver JMJ, Ross-Innes CS, Shannon N, Lynch AG, Forshew T, Barbera M, Murtaza M, Ong CJ, Lao-Sirieix P, Dunning MJ, Smith L, Smith ML, Anderson CL, Carvalho B, O'Donovan M, Underwood TJ, May AP, Grehan N, Hardwick R, Davies J, Oloumi A, Aparicio S, Caldas C, Eldridge MD, Edwards PAW, Rosenfeld N, Tavare S, Fitzgerald RC; OCCAMS consortium. Ordering of mutations in preinvasive disease stages of esophageal carcinogenesis. Nat Genet. 2014 Aug;46(8):837-843. doi: 10.1038/ng.3013. Epub 2014 Jun 22.
- Background: PubMed 3402983Hamilton SR, Smith RR, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol. 1988 Aug;19(8):942-8. doi: 10.1016/s0046-8177(88)80010-8.
- Background: PubMed 25071900di Pietro M, Alzoubaidi D, Fitzgerald RC. Barrett's esophagus and cancer risk: how research advances can impact clinical practice. Gut Liver. 2014 Jul;8(4):356-70. doi: 10.5009/gnl.2014.8.4.356. Epub 2014 Jul 1.
- Background: PubMed 21376940American Gastroenterological Association; Spechler SJ, Sharma P, Souza RF, Inadomi JM, Shaheen NJ. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011 Mar;140(3):1084-91. doi: 10.1053/j.gastro.2011.01.030. No abstract available.
- Background: PubMed 20032324Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available.
- Background: PubMed 23303625Hur C, Miller M, Kong CY, Dowling EC, Nattinger KJ, Dunn M, Feuer EJ. Trends in esophageal adenocarcinoma incidence and mortality. Cancer. 2013 Mar 15;119(6):1149-58. doi: 10.1002/cncr.27834. Epub 2012 Dec 11.
- Background: PubMed 18550563Yousef F, Cardwell C, Cantwell MM, Galway K, Johnston BT, Murray L. The incidence of esophageal cancer and high-grade dysplasia in Barrett's esophagus: a systematic review and meta-analysis. Am J Epidemiol. 2008 Aug 1;168(3):237-49. doi: 10.1093/aje/kwn121. Epub 2008 Jun 12.
- Background: PubMed 21995385Hvid-Jensen F, Pedersen L, Drewes AM, Sorensen HT, Funch-Jensen P. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med. 2011 Oct 13;365(15):1375-83. doi: 10.1056/NEJMoa1103042.
- Background: PubMed 20094044Reid BJ, Li X, Galipeau PC, Vaughan TL. Barrett's oesophagus and oesophageal adenocarcinoma: time for a new synthesis. Nat Rev Cancer. 2010 Feb;10(2):87-101. doi: 10.1038/nrc2773.
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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.
Ajay Bansal, MD principal investigator
Veterans Affairs Medical Center and the University of Kansas 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, 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ajay Bansal, MD (57790, ajay.bansal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia (time frame: 1-3 years). 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 NCT02464930, which also lists 43 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 8 Jun 2015.