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The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

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: NCT03377972
Recruitment Status : Unknown
Verified December 2017 by Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
Endoscopic Submucosal Dissection (ESD) is currently the main method of treatment of early esophageal cancer and precancerous lesions. Therefore, the investigators are looking forward to conduct a cohort study on early esophageal cancer patients undergoing endoscopic treatment collected from Zhongshan Hospital, Fudan University, comparing the WHO standard with Japanese standard of endoscopic therapy diagnosis. In addition,the investigators will collect patients' detailed informations and analyze the risk factors for metastasis and recurrence of early esophageal cancer.

Condition or disease
Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
WHO diagnostic standard
Japan diagnostic standard



Primary Outcome Measures :
  1. Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section. [ Time Frame: December 1st,2017-December 1st,2018 ]
    Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Early esophageal cancer and precancerous lesions patients undergoing endoscopic resection therapy for the first time in zhongshan hospital from September 1, 2014 to September 1,2017.
  2. Early esophageal cancer and precancerous lesions patients undergoing endoscopic resection therapy for the first time in zhongshan hospital after September 1,2017.
Criteria

Inclusion Criteria:

  1. Older than 15-year-old
  2. Undergoing endoscopic Submucosal Dissection (ESD) in ZhongShan Hospital

Exclusion Criteria:

Preoperative patients with recurrence and Lost to follow-up of patients within 1 year

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03377972    
Other Study ID Numbers: B2017-130
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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