Classification of Adenocarcinoma of the Esophagogastric J... | NCT04151524

Studies
Classification of Adenocarcinoma of the Esophagogastric Junction

NCT04151524

Sponsor

St. James's Hospital, Ireland

Status

Unknown status

Last Update Posted

Nov 5, 2019Actual

Enrollment

1,658Actual

Phase

Not provided

Conditions

Oesophagus Cancer
Barrett Esophagus
Siewert Type I Adenocarcinoma of Esophagogastric Junction
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Siewert Type III Adenocarcinoma of Esophagogastric Junction

Interventions

Not provided

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2019Actual

Primary Completion Date

Dec 25, 2019Estimated

Completion Date

Feb 1, 2020Estimated

First Submitted Date

Oct 23, 2019

First Submission Date that Met QC Criteria

Nov 2, 2019

First Posted Date

Nov 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2019

Last Update Posted Date

Nov 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Noel Edward Donlon, Principal Investigator, St. James's Hospital, IrelandPrincipal Investigator

Lead Sponsor

St. James's Hospital, IrelandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Siewert classification of oesophageal cancer is the standard approach in anatomically subdividing cancer of the lower oesohagus.

Detailed Description

Retrospective review of tumour biology, pathological staging and outcomes in the participants based on Siewert classification. The investigators to scrutinise this scoring system to evaluate if it is indeed appropriate.

Conditions Module

Conditions

Oesophagus Cancer
Barrett Esophagus
Siewert Type I Adenocarcinoma of Esophagogastric Junction
Siewert Type II Adenocarcinoma of Esophagogastric Junction
Siewert Type III Adenocarcinoma of Esophagogastric Junction

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,658Actual

Measure	Description	Time Frame
Overall Survival		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Observational study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. James's Hospital		Dublin	IE	D8	Ireland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D004938	Esophageal Neoplasms
D001471	Barrett Esophagus

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D011230	Precancerous Conditions