Barrett EsophagusNCT03216135
Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
An observational study of Barrett Esophagus and Esophageal Cancer, run by Ochsner Health System at 1 site in United States.
Trial summary
This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 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: Approximately 10 samples of 3 specific tissue types (specified as the 3 groups) will be collected as well as control samples. The number of patients enrolled may vary due to the variance of tissue type per patient. Patients will be informed that the number of patients enrolled will depend on the number of tissues needed for the study.
Who may be able to join
- Male or females >18 years of age with known or suspected GERD, Barrett's Esophagus and or esophageal adenocarcinoma or from patients who have a history of either condition.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
April Wendt contact
United States1 site, 1 recruiting
- Recruiting
Ochsner Health System
Kenner, Louisiana, 70065
Cris Molina, 504-464-8314, cris.molina@ochsner.org
April Wendt, RN, 504-464-8499, awendt@ochsner.org
About this study
This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.
Read the detailed description
Gastroesophageal reflux disease, GERD, can lead to a change of the esophagus lining to a protective cell type, termed Barrett's esophagus (BE). A diagnosis of BE greatly increases the risk of developing esophageal adenocarcinoma (EAC). The incidence of EAC has been rapidly rising in the last 30 years, and the cancer has a high mortality rate. Understanding the involvement of the esophageal microbiota could lead to prevention strategies to this increasing health concern.
This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Keywords
- Microbiome
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
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 |
|---|---|---|
| (GERD) with no Barrett's Esophagus | Squamous epithelium from patient with gastroesophageal reflux disease (GERD) with no BE or EAC diagnosed will be collected and a control sample (area with no disease). | |
| Barrett's Esophagus | BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease). | |
| Cancer Tissue | Cancer tissue, and a control squamous epithelium from the same patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial community profiling
16S Ribosomal RNA (rRNA)gene sequencing
Measured: 9 months
Secondary outcomes (1)
Generate a tissue microarray
After retrieval of blocks, an experienced pathologist will mark the relevant tissue areas to process into microarray
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start20 Jul 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Principal investigator, Virendra Joshi, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216135
- Sponsor's protocol ID
- 2017113
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Involvement With Barrett's Esophagus and Progression to Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03216135
- Acronym / sponsor ID
- 2017113
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- 20 Jul 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Jul 2017 (actual)
- 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.
This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.
Detailed description
Gastroesophageal reflux disease, GERD, can lead to a change of the esophagus lining to a protective cell type, termed Barrett's esophagus (BE). A diagnosis of BE greatly increases the risk of developing esophageal adenocarcinoma (EAC). The incidence of EAC has been rapidly rising in the last 30 years, and the cancer has a high mortality rate. Understanding the involvement of the esophageal microbiota could lead to prevention strategies to this increasing health concern.
This study will examine the hypothesis that altered esophageal microbiome leads to the development of esophageal adenocarcinoma (EAC). The aims of the project are, firstly the confirmation of relational data on the study cohort, using the methods developed and applied at the laboratory at University of Queensland Diamantina Institute (UQDI). Second, to generate a tissue microarray resource future tissue in-situ validation of microbes. And finally, to develop a biobank of clinical isolates of relevant esophageal microbes for future functional studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (GERD) with no Barrett's Esophagus | – | –Squamous epithelium from patient with gastroesophageal reflux disease (GERD) with no BE or EAC diagnosed will be collected and a control sample (area with no disease). |
| Barrett's Esophagus | – | –BE/columnar epithelium from patient diagnosed with BE and a control sample (area with no disease). |
| Cancer Tissue | – | –Cancer tissue, and a control squamous epithelium from the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 10 samples of 3 specific tissue types (specified as the 3 groups) will be collected as well as control samples. The number of patients enrolled may vary due to the variance of tissue type per patient. Patients will be informed that the number of patients enrolled will depend on the number of tissues needed for the study.
Key inclusion criteria (1 listed)
- Male or females >18 years of age with known or suspected GERD, Barrett's Esophagus and or esophageal adenocarcinoma or from patients who have a history of either condition.
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
Microbial community profiling
Time frame: 9 months
16S Ribosomal RNA (rRNA)gene sequencing
1 secondary outcome
Generate a tissue microarray
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: No
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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.
April Wendt contact
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 Esophagus and Esophageal Cancer, run by Ochsner Health System 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 1 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: status not confirmed, as of the sponsor's last update on 13 Jul 2017. 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 Virendra Joshi, MD (504-842-7690, vjoshi@ochsner.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial community profiling (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2017.