NCT03685799

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

December 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

September 24, 2018

Last Update Submit

December 13, 2018

Conditions

Barretts Esophagus With Dysplasia

Keywords

Barretts EsophagusDysplasia

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Identification of histological factors of recurrence.

    1 day

Study Arms (1)

DHG on Barrett's esophagus

patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection

Diagnostic Test: Pathological revision

Interventions

Pathological revisionDIAGNOSTIC_TEST

Pathological revision

DHG on Barrett's esophagus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

You may qualify if:

  • patients with DHG on Barrett's esophagus on endoscopic biopsies followed by endoscopic resection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

Location

Related Publications (1)

  • 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.

    PMID: 28078459RESULT

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

May 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

December 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)