Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE" (OESOFARE)

March 12, 2025 updated by: Nantes University Hospital

Status of Superficial Esophageal Cancers Treated by Endoscopy

In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This fundamental study will therefore best describe current French practices for the management strategy of esophageal cancers after endoscopic treatment. Consequently, the interests of this study, national inventory, are multiple:

  1. List a significant number of endoscopic treatments. In particular, by sub mucosal dissection in France, in order to strengthen scientific evidence of its efficacy, to assess its feasibility and complication rate.
  2. Describe the therapeutic strategies currently in place during endoscopic treatment,
  3. Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Contacts and Locations

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

Study Locations

  • France
      • Nantes, France, 44000
        • CHU Nantes

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The investigator will propose the study to any patient with esophageal cancer (adenocarcinoma or squamous cell carcinoma) or histologically proven high grade dysplasia and having an endoscopy for endoscopic resection of his oesophageal cancer or dysplasia. At least 100 patients will be included in the study

Description

Inclusion Criteria:

  • Male or female over 18 years of age
  • Patient with histologically proven high-grade esophageal cancer (adenocarcinoma or squamous cell carcinoma) or dysplasia
  • Patient with digestive endoscopy for endoscopic resection (mucosectomy or submucosal dissection) of a cancerous lesion (adenocarcinoma or squamous cell carcinoma) of the esophagus or high-grade dysplasia.
  • Patient who received the study briefing note and agreed to participate

Exclusion Criteria:

  • Failure to perform the endoscopic procedure
  • Patient under guardianship or guardianship or under judicial safeguard measure
  • Pregnant woman
  • Patient with prior treatment for esophageal cancer.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of different managements according to the described method : The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon (Gastrointest. Endosc. 58, S3-43 (2003)
Time Frame: at the endoscopic resection procedure
In this visit we noted the management by type and histological classification of superficial esophageal tumours
at the endoscopic resection procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adequacy between the proposed management before the endoscopic procedure and the actual management
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of adequacy between the proposed management before the endoscopic procedure and the actual management, defined by the respect of the envisaged strategy and timing
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of complete resection R0 after endoscopic treatment
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of complete resection R0 after endoscopic treatment
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients with endoscopic complication per procedure and/or delayed
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients with endoscopic complication per procedure (esophageal perforation, bleeding) and/or delayed (delayed bleeding, esophageal stenosis)
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients treated with mucosectomy or submucosal dissection
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients treated with mucosectomy or submucosal dissection
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients having, in the month following the complementary treatment, an adverse effect
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients having, in the month following the complementary treatment, an adverse effect such as fever, haemorrhage, retrosternal pain, food blockages or weight loss
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with a recurrence of cancerous lesion at the initial resection site or at a distance, histologically proven, during follow-up consultations at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post treatment.
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with recurrence having had a simple monitoring (= therapeutic abstention), endoscopic re-treatment, surgery or radiochemotherapy
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Number of patients with recurrence having had a simple monitoring, endoscopic re-treatment, surgery or radiochemotherapy
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"Esophageal Symptoms" questionnaire
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Esophageal Symptoms questionnaires will be filled by the physician at each visit
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"SF36" questionnaire
Time Frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"SF36" questionnaires will be filled by the physician at each visit
at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC18_0075

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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