Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia (NC-ESD)

September 21, 2020 updated by: Universidade do Porto

Multi-center Survey on Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Short and long outcomes of ESD are well described, particularly in Eastern series. However, the outcome of non-curative ESDs is scarcely reported in the west (particularly among non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the European experience with non-curative ESDs, analysing all the consecutive ESDs performed in several reference centers, assessing the presence of residual lesion in the endoscopic follow-up or in the surgical specimen.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Porto, Portugal
        • Recruiting
        • Hospital S. João
        • Contact:
          • João Antunes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract.

Description

Inclusion Criteria:

  • All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract

Exclusion Criteria:

  • Patients without endoscopic follow-up or surgery will be excluded from the analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual neoplasia
Time Frame: 2010-2020
Presence of residual neoplasia after non-curative ESD
2010-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Investigators

  • Principal Investigator: João Santos-Antunes, Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
  • Study Director: Guilherme Macedo, MD, PhD, Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Non-Curative ESDs Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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