Barretts Esophagus With DysplasiaPatheBarettNCT03685799
Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia
An observational study of Barretts Esophagus With Dysplasia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Influence of histological concordance on the risk of recurrence: the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barretts Esophagus With Dysplasia
- What is being tested?
- Pathological revision
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Jun 2016
- 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: patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Who may be able to join
- patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Read the detailed description
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
- Conditions
- Barretts Esophagus With Dysplasia
- Being tested
- Pathological revision
- Keywords
- Barretts Esophagus, Dysplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathological revisionDiagnostic test
Pathological revision
| Study group | Role | What they receive |
|---|---|---|
| DHG on Barrett's esophagus | patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection Receives: Diagnostic Test: Pathological revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of histological concordance on the risk of recurrence
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Measured: 1 day
Secondary outcomes (1)
Identification of histological factors of recurrence.
Identification of histological factors of recurrence.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barretts Esophagus With DysplasiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685799
- Sponsor's protocol ID
- PatheBarett-IPC 2016-005
- Acronym
- PatheBarett
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godat S, Caillol F, Autret A, Bories E, Pesenti C, Ratone JP, De Cassan C, Poizat F, Giovannini M. Endotherapy in case of relapse of neoplastic Barrett's esophagus after successful initial endoscopic resection. Surg Endosc. 2017 Sep;31(9):3703-3710. doi: 10.1007/s00464-016-5409-5. Epub 2017 Jan 11.
PubMed 28078459
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Histologic Concordance Between Biopsies and the Endoscopic Resection Specimen, in the Treatment of Barrett's Esophagus in Dysplasia, on the Recurrence of Dysplasia
- ClinicalTrials.gov ID
- NCT03685799
- Acronym / sponsor ID
- PatheBarett / PatheBarett-IPC 2016-005
- Conditions
- Barretts Esophagus With Dysplasia
- Keywords
- Barretts Esophagus, Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Sep 2018 (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.
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Detailed description
Influence of histological concordance on the risk of recurrence:
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHG on Barrett's esophagus | – | Diagnostic Test: Pathological revisionpatients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Key inclusion criteria (1 listed)
- patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathological revisionPathological revision | Diagnostic test | DHG on Barrett's esophagus |
Primary outcome
Influence of histological concordance on the risk of recurrence
Time frame: 1 day
the histological concordance being the comparison between the biopsies and the endoscopic resection piece and its concordant response rate.
1 secondary outcome
Identification of histological factors of recurrence.
Time frame: 1 day
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 14 Dec 2018.
- Results publication: PubMed 28078459Godat S, Caillol F, Autret A, Bories E, Pesenti C, Ratone JP, De Cassan C, Poizat F, Giovannini M. Endotherapy in case of relapse of neoplastic Barrett's esophagus after successful initial endoscopic resection. Surg Endosc. 2017 Sep;31(9):3703-3710. doi: 10.1007/s00464-016-5409-5. Epub 2017 Jan 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Barretts Esophagus With Dysplasia, run by Institut Paoli-Calmettes at 1 site in France.
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: finished, as of the sponsor's last update on 14 Dec 2018. 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 France. 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?
Influence of histological concordance on the risk of recurrence (time frame: 1 day). 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 NCT03685799, which also lists 1 linked publication.
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 14 Dec 2018.