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

December 16, 2017 updated by: Shanghai Zhongshan Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
WHO diagnostic standard
Japan diagnostic standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 1st,2017-December 1st,2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

December 16, 2017

First Posted (Actual)

December 19, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 16, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2017-130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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