NCT03377972

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

November 12, 2017

Last Update Submit

December 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

WHO diagnostic standard

Japan diagnostic standard

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2017

First Posted

December 19, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 19, 2017

Record last verified: 2017-12