Barrett's EsophagusNCT00844077
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
An observational study of Barrett's Esophagus, run by University of Michigan at 6 sites in 2 countries.
Trial summary
Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 255 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2007to Apr 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing clinically-indicated upper endoscopy for surveillance of their pathologically-confirmed Barrett's intestinal metaplasia. Recruitment is from the Endoscopy schedules of the collaborating locations.
Who may be able to join
- Adults (> 18 years old)
- Subjects with pathologically confirmed Barrett's esophagus, including:
- Intestinal metaplasia without dysplasia, long and short segments (>1 cm)
- Intestinal metaplasia without dysplasia, long and short segments (>1 cm), previously in GLNE 003
- Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite-for-dysplasia) provided there is no history of HGD, or EAC.
- Intestinal metaplasia without dysplasia or indefinite-for-dysplasia with a history of LGD provided the last surveillance endoscopy showed IM alone, the LGD history was at least 12 or more months ago and there is no history of HGD or EAC.
Show all 19Show fewer
- Able to physically tolerate removal of 34 ml of blood
- Tolerate extra research related biopsies and brushings
- Willing to permit extra biopsies at future endoscopic procedures
- Ability and willingness to complete questionnaires
- Willing to sign informed consent Exclusion Criteria
- Subjects with a pathologically confirmed history of Barrett's, HGD or EAC
- Subjects with pathologically confirmed history of Barrett's LGD within the last 12 months.
- Subjects in whom esophageal biopsy would be contraindicated (eq. varices)
- Subjects with serious infections requiring IV antibiotics
- Subjects with known HIV or chronic viral hepatitis
- Subjects on active chemotherapy or radiation treatment
- Subjects who have had an esophagectomy
- Subjects with an active malignancy diagnosed or treated within 3 years except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin; Carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
Who cannot join
None listed.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts
MD Anderson Cancer Center
Houston, Texas
Columbia University
New York, New York
Mt. Sinai School of Medicine
New York, New York
About this study
Official title: Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma
Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study.
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Intestinal Metaplasia
- Medical subject headings
- Barrett 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 |
|---|---|---|
| Barrett's metaplasia | Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma.
Measured: 5-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 only
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Early Detection Research Network, M.D. Anderson Cancer Center, Unity Health Toronto, Dana-Farber Cancer Institute, Dartmouth-Hitchcock Medical Center, Columbia University, Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Missy Tuck, University of Michigan
- Investigators
- Dean E Brenner, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844077
- Sponsor's protocol ID
- GLNE 008
- Other IDs
- 5U01CA086400-08
- Status last verified
- Dec 2011
- First submitted
- 12 Feb 2009
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00844077
- Acronym / sponsor ID
- GLNE 008
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Intestinal Metaplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Early Detection Research Network, M.D. Anderson Cancer Center, Unity Health Toronto, Dana-Farber Cancer Institute, Dartmouth-Hitchcock Medical Center, Columbia University, Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Apr 2011 (actual)
- First posted
- 13 Feb 2009 (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.
Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's metaplasia | – | –Barrett's intestinal metaplasia, confirmed via pathology, undergoing standard of care endoscopic screening. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing clinically-indicated upper endoscopy for surveillance of their pathologically-confirmed Barrett's intestinal metaplasia. Recruitment is from the Endoscopy schedules of the collaborating locations.
Key inclusion criteria (19 listed)
- Adults (> 18 years old)
- Subjects with pathologically confirmed Barrett's esophagus, including:
- Intestinal metaplasia without dysplasia, long and short segments (>1 cm)
- Intestinal metaplasia without dysplasia, long and short segments (>1 cm), previously in GLNE 003
- Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite-for-dysplasia) provided there is no history of HGD, or EAC.
Key exclusion criteria (0 listed)
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
Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma.
Time frame: 5-8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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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.
Dean E Brenner, MD principal investigator
University of Michigan
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus, run by University of Michigan at 6 sites in 2 countries.
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 19 inclusion and 0 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: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conversion from Barrett's intestinal metaplasia to dysplasia or esophageal adenocarcinoma. (time frame: 5-8 years). 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 7 Dec 2011.