Superficial Esophageal CancersOESOFARENCT03674801
Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"
An observational study of Superficial Esophageal Cancers, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Esophageal Cancers
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2019to 26 Feb 2025
- How long will I take part?
- 3 Years
- 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: 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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:
- 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.
- Describe the therapeutic strategies currently in place during endoscopic treatment,
- Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.
- Conditions
- Superficial Esophageal Cancers
- Keywords
- Superficial esophageal cancer, Endoscopic mucosectomy, Submucosal dissection, therapeutic strategy
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
In this visit we noted the management by type and histological classification of superficial esophageal tumours
Measured: at the endoscopic resection procedure
Secondary outcomes (9)
Adequacy between the proposed management before the endoscopic procedure and the actual management
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
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of complete resection R0 after endoscopic treatment
Percentage of complete resection R0 after endoscopic treatment
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients with endoscopic complication per procedure and/or delayed
Percentage of patients with endoscopic complication per procedure (esophageal perforation, bleeding) and/or delayed (delayed bleeding, esophageal stenosis)
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Percentage of patients treated with mucosectomy or submucosal dissection
Percentage of patients treated with mucosectomy or submucosal dissection
Measured: 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
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
Measured: 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
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.
Measured: 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
Number of patients with recurrence having had a simple monitoring, endoscopic re-treatment, surgery or radiochemotherapy
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"Esophageal Symptoms" questionnaire
Esophageal Symptoms questionnaires will be filled by the physician at each visit
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
"SF36" questionnaire
"SF36" questionnaires will be filled by the physician at each visit
Measured: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start26 Feb 2019
- Primary completion26 Feb 2022
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Esophageal CancersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674801
- Sponsor's protocol ID
- RC18_0075
- Acronym
- OESOFARE
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2018
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status of Superficial Esophageal Cancers Treated by Endoscopy
- ClinicalTrials.gov ID
- NCT03674801
- Acronym / sponsor ID
- OESOFARE / RC18_0075
- Conditions
- Superficial Esophageal Cancers
- Keywords
- Superficial esophageal cancer, Endoscopic mucosectomy, Submucosal dissection, therapeutic strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 18 Sep 2018 (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.
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
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:
- 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.
- Describe the therapeutic strategies currently in place during endoscopic treatment,
- Evaluate the adequacy between the proposed upstream management of the endoscopic procedure by SCP and the actual management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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
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
9 secondary outcomes
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 complete resection R0 after endoscopic treatment
Time frame: 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 treated with mucosectomy or submucosal dissection
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
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
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 (= therapeutic abstention), endoscopic re-treatment, surgery or radiochemotherapy
Time frame: 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
"SF36" questionnaire
Time frame: at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Superficial Esophageal Cancers, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.