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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674801
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : September 5, 2023
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date July 11, 2018
First Posted Date September 18, 2018
Last Update Posted Date September 5, 2023
Actual Study Start Date February 26, 2019
Actual Primary Completion Date February 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 17, 2018)
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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.
  • 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
  • "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
  • "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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE"
Official Title Status of Superficial Esophageal Cancers Treated by Endoscopy
Brief 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. 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:

  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 Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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
Condition Superficial Esophageal Cancers
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 17, 2021)
200
Original Estimated Enrollment
 (submitted: September 17, 2018)
100
Estimated Study Completion Date February 26, 2027
Actual Primary Completion Date February 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03674801
Other Study ID Numbers RC18_0075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Nantes University Hospital
Original Responsible Party Same as current
Current Study Sponsor Nantes University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date September 2023