Fundic Gland PolypsNCT01130363
Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
An observational study of Fundic Gland Polyps, run by Columbia University at 1 site in United States.
Trial summary
The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Fundic Gland Polyps
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2012
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals found to have fundic gland polyps on endoscopic evaluation and are on proton pump inhibitor (PPI), individuals found to have fundic gland polyps on endoscopic evaluation but are not on PPI or patients on PPI but had no fundic gland polyps found on endoscopic evaluation (control group).
Who may be able to join
- Age 18 and above.
- Able and willing to sign informed consent.
- The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.
Who cannot join
- Unwilling or unable to sign informed consent for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs
The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.
- Conditions
- Fundic Gland Polyps
- Keywords
- Proton Pump Inhibitor, Gastric carcinoid tumors, Gastric cancer, Fundic Gland Polyps
- Medical subject headings
- Polyposis, Gastric, Stomach 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 |
|---|---|---|
| Fundic Gland Polyps on PPI | Patients found to have fundic gland polyps on endoscopic evaluation that have also been prescribed and regularly take a proton pump inhibitor. | |
| Fundic Gland Polyp not on PPI | Patients found to have fundic gland polyps on endoscopic evaluation that have not been prescribed a proton pump inhibitor. | |
| Group 3 (Control Group) | Individuals who are prescribed proton pump inhibitor but are not found to have fundic gland polyps on endoscopic evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with fundic gland polyps and PPI use that have a higher gastric pH
We aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. We believe there is a correlation between fundic gland polyps of the stomach and use of proton pump inhibiter medications.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startOct 2006
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Poor Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fundic Gland PolypsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold Frucht, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130363
- Sponsor's protocol ID
- AAAC2805
- Status last verified
- Jun 2012
- First submitted
- 21 May 2010
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs
- ClinicalTrials.gov ID
- NCT01130363
- Acronym / sponsor ID
- AAAC2805
- Conditions
- Fundic Gland Polyps
- Keywords
- Proton Pump Inhibitor, Gastric carcinoid tumors, Gastric cancer, Fundic Gland Polyps
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor Enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 May 2010 (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 class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fundic Gland Polyps on PPI | – | –Patients found to have fundic gland polyps on endoscopic evaluation that have also been prescribed and regularly take a proton pump inhibitor. |
| Fundic Gland Polyp not on PPI | – | –Patients found to have fundic gland polyps on endoscopic evaluation that have not been prescribed a proton pump inhibitor. |
| Group 3 (Control Group) | – | –Individuals who are prescribed proton pump inhibitor but are not found to have fundic gland polyps on endoscopic evaluation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals found to have fundic gland polyps on endoscopic evaluation and are on proton pump inhibitor (PPI), individuals found to have fundic gland polyps on endoscopic evaluation but are not on PPI or patients on PPI but had no fundic gland polyps found on endoscopic evaluation (control group).
Key inclusion criteria (3 listed)
- Age 18 and above.
- Able and willing to sign informed consent.
- The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.
Key exclusion criteria (1 listed)
- Unwilling or unable to sign informed consent for the study.
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
Number of patients with fundic gland polyps and PPI use that have a higher gastric pH
Time frame: Up to 1 year
We aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. We believe there is a correlation between fundic gland polyps of the stomach and use of proton pump inhibiter medications.
Results and safety
The study was stopped early (reason given: Poor Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
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Familial Adenomatous Polyposis
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.
Harold Frucht, MD principal investigator
Columbia University
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 Fundic Gland Polyps, run by Columbia University 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 2 Jul 2012. 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: Poor Enrollment). 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?
Number of patients with fundic gland polyps and PPI use that have a higher gastric pH (time frame: Up to 1 year). 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 2 Jul 2012.