The Cohort Study of Early Esophageal Cancer or Precancero... | NCT03377972

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

NCT03377972

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Dec 19, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Dec 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Nov 12, 2017

First Submission Date that Met QC Criteria

Dec 16, 2017

First Posted Date

Dec 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2017

Last Update Posted Date

Dec 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section.	Comparison WHO diagnosis standard with JAPAN in Early Esophageal Cancer patients by accessing pathological section.	December 1st,2017-December 1st,2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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.
Early esophageal cancer and precancerous lesions patients undergoing endoscopic resection therapy for the first time in zhongshan hospital after September 1,2017.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
WHO diagnostic standard
Japan diagnostic standard