Barrett EsophagusNCT04642690
Nitrates and IL-8 in Barrett's Esophagus
An observational study of Barrett Esophagus and Esophageal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2020to 9 Dec 2022
- 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: Adult individuals scheduled for clinically indicated EGD procedure. Subjects with normal squamous epithelium, erosive esophagitis, or varying degrees of Barrett's Esophagus may be enrolled.
Who may be able to join
- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).
Who cannot join
- Comorbid inflammatory medical condition.
- Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.
- Use of nitrate containing medication in the past 1 week.
- Consumption of nitrate rich foods in preceding 24 hours.
- Known allergy to meat or nitrates
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma
The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Medical subject headings
- Barrett Esophagus, 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 |
|---|---|---|
| Group 1-NSE | Patients found to have grossly normal squamous epithelium during endoscopy | |
| Group 2-EEG | Patients found to have grossly apparent erosive esophagitis >1cm with Los Angeles Classification A-D | |
| Group 3-NDBE Short | Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Short Segment) | |
| Group 4-NDBE Long | Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Long Segment) | |
| Group 5 | Barrett's Esophagus (BE) with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) | |
| Group 6-Esophagectomy | Patients undergoing resection of esophageal cancer | |
| Group -7 Pilot and Feasibility | Patients undergoing EGD with NSE, NDBE, BE-HGD, or EAC for feasibility of analytical techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitrate Levels
Nitrate levels in serum, saliva and tissue in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or EAC
Measured: Baseline
Serum and Tissue Biomarkers
Levels of IL-8 in patients diagnosed BE dysplasia and EAC
Measured: Baseline
Secondary outcomes (1)
Biomarkers and disease progression
Level of IL-8 in serum and tissue in patients with NDBE that progressed to BE
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start24 Sep 2020
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: could not collect adequate samples
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cadman Leggett, Mayo Clinic
- Investigators
- Cadman Leggett, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642690
- Sponsor's protocol ID
- 20-004618
- Status last verified
- Dec 2022
- First submitted
- 9 Oct 2020
- Last updated
- 15 Dec 2022
- 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett's Esophagus and Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04642690
- Acronym / sponsor ID
- 20-004618
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: could not collect adequate samples
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 24 Nov 2020 (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.
The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1-NSE | – | –Patients found to have grossly normal squamous epithelium during endoscopy |
| Group 2-EEG | – | –Patients found to have grossly apparent erosive esophagitis >1cm with Los Angeles Classification A-D |
| Group 3-NDBE Short | – | –Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Short Segment) |
| Group 4-NDBE Long | – | –Patients with non-dysplastic Barrett's Esophagus (NDBE) > 1cm (Long Segment) |
| Group 5 | – | –Barrett's Esophagus (BE) with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) |
| Group 6-Esophagectomy | – | –Patients undergoing resection of esophageal cancer |
| Group -7 Pilot and Feasibility | – | –Patients undergoing EGD with NSE, NDBE, BE-HGD, or EAC for feasibility of analytical techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals scheduled for clinically indicated EGD procedure. Subjects with normal squamous epithelium, erosive esophagitis, or varying degrees of Barrett's Esophagus may be enrolled.
Key inclusion criteria (1 listed)
- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).
Key exclusion criteria (5 listed)
- Comorbid inflammatory medical condition.
- Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.
- Use of nitrate containing medication in the past 1 week.
- Consumption of nitrate rich foods in preceding 24 hours.
- Known allergy to meat or nitrates
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
Nitrate Levels
Time frame: Baseline
Nitrate levels in serum, saliva and tissue in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or EAC
Serum and Tissue Biomarkers
Time frame: Baseline
Levels of IL-8 in patients diagnosed BE dysplasia and EAC
1 secondary outcome
Biomarkers and disease progression
Time frame: Baseline
Results and safety
The study was stopped early (reason given: could not collect adequate samples). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- 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.
Cadman Leggett, MD principal investigator
Mayo Clinic
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 Adenocarcinoma, run by Mayo Clinic 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 5 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 15 Dec 2022. 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: could not collect adequate samples). 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?
Nitrate Levels (time frame: Baseline). The study lists 2 primary outcomes in all. 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 15 Dec 2022.