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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674801
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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


Condition or disease
Superficial Esophageal Cancers

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Status of Superficial Esophageal Cancers Treated by Endoscopy
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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.

  7. 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

  8. "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

  9. "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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674801


Locations
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France
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Emmanuel Coron, MD    (0)2-40-08-31-51 ext +33    emmanuel.coron@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03674801    
Other Study ID Numbers: RC18_0075
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Superficial esophageal cancer
Endoscopic mucosectomy
Submucosal dissection
therapeutic strategy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases