Status of Superficial Esophageal Cancers Treated by Endoscopy "OESOFARE" (OESOFARE)
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ClinicalTrials.gov Identifier: NCT03674801 |
Recruitment Status :
Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : September 5, 2023
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Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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 |
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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:
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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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. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
200 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |