Gastric NeoplasmNC-ESDNCT04484311
Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia
An observational study of Gastric Neoplasm and Esophageal Neoplasms, run by Universidade do Porto at 1 site in Portugal.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasm, Esophageal Neoplasms, Colorectal Neoplasms
- How many people
- 300 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Aug 2020to Dec 2020
- 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: All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract.
Who may be able to join
- All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract
Who cannot join
- Patients without endoscopic follow-up or surgery will be excluded from the analysis
Trial locations and contacts
1 site in 1 country.
Guilherme Macedo, MD, PhD contact
About this study
Official title: 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.
- Conditions
- Gastric Neoplasm, Esophageal Neoplasms, Colorectal Neoplasms
- Keywords
- Endoscopic therapy, Endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual neoplasia
Presence of residual neoplasia after non-curative ESD
Measured: 2010-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Aug 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric NeoplasmStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Santos-Antunes, Principal investigator, Gastrointestinal Department, Centro Hospitalar S. João, Porto, PortugalGuilherme Macedo, MD, PhD, Study director, Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484311
- Sponsor's protocol ID
- Non-Curative ESDs Registry
- Acronym
- NC-ESD
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.
PubMed 37666656Santos-Antunes J, Pioche M, Ramos-Zabala F, Cecinato P, Gallego Rojo FJ, Barreiro P, Felix C, Sferrazza S, Berr F, Wagner A, Lemmers A, Figueiredo Ferreira M, Albeniz E, Uchima H, Kuttner-Magalhaes R, Fernandes C, Morais R, Gupta S, Martinho-Dias D, Rios E, Faria-Ramos I, Marques M, Bourke MJ, Macedo G. Risk of residual neoplasia after a noncurative colorectal endoscopic submucosal dissection for malignant lesions: a multinational study. Endoscopy. 2023 Mar;55(3):235-244. doi: 10.1055/a-1906-8000. Epub 2022 Jul 21.
PubMed 35863354
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Survey on Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia
- ClinicalTrials.gov ID
- NCT04484311
- Acronym / sponsor ID
- NC-ESD / Non-Curative ESDs Registry
- Conditions
- Gastric Neoplasm, Esophageal Neoplasms, Colorectal Neoplasms
- Keywords
- Endoscopic therapy, Endoscopic submucosal dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jul 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract.
Key inclusion criteria (1 listed)
- All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract
Key exclusion criteria (1 listed)
- Patients without endoscopic follow-up or surgery will be excluded from the analysis
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
Residual neoplasia
Time frame: 2010-2020
Presence of residual neoplasia after non-curative ESD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 37666656Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.
- Derived from this study: PubMed 35863354Santos-Antunes J, Pioche M, Ramos-Zabala F, Cecinato P, Gallego Rojo FJ, Barreiro P, Felix C, Sferrazza S, Berr F, Wagner A, Lemmers A, Figueiredo Ferreira M, Albeniz E, Uchima H, Kuttner-Magalhaes R, Fernandes C, Morais R, Gupta S, Martinho-Dias D, Rios E, Faria-Ramos I, Marques M, Bourke MJ, Macedo G. Risk of residual neoplasia after a noncurative colorectal endoscopic submucosal dissection for malignant lesions: a multinational study. Endoscopy. 2023 Mar;55(3):235-244. doi: 10.1055/a-1906-8000. Epub 2022 Jul 21.
- 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.
Guilherme Macedo, MD, PhD contact
João Santos-Antunes principal investigator
Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
Guilherme Macedo, MD, PhD study director
Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal
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 Gastric Neoplasm and Esophageal Neoplasms, run by Universidade do Porto at 1 site in Portugal.
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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Santos-Antunes, MD, MSc (+351917490406, joao.claudio.antunes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual neoplasia (time frame: 2010-2020). 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 NCT04484311, which also lists 2 linked publications.
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 23 Sep 2020.