An Observational Study to Evaluate Lymph Metastases and P... | NCT03415815

Studies
An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer

NCT03415815

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

Jan 30, 2018Actual

Enrollment

3,673Estimated

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Surgeries

Countries

China

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2017Actual

Primary Completion Date

Apr 30, 2018Estimated

Completion Date

Apr 30, 2018Estimated

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 30, 2018Actual

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

Jan 23, 2018

Last Update Posted Date

Jan 30, 2018Actual

Name	Class
LinkDoc Technology (Beijing) Co. Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer

Detailed Description

This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.

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

3,673Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T1-T3 esophageal cancer		Pathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries	Procedure: Surgeries

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgeries	Procedure	Radical resection of esophageal cancer	T1-T3 esophageal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of lymph nodes and percentages of patients with surgeries	Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer	1999 - 2017

Secondary Outcomes

Measure	Description	Time Frame
Impact factors of lymph metastases	Impact factors of lymph metastases	1999 - 2017

Other Outcomes

Measure	Description	Time Frame
Effects of lymph metastases on overall survival	Effects on lymph metastases on overall survival in the patients with thoracic esophageal cancer	1999 - 2017
Effects of the numbers of lymph nodes on overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >= 18 years old;
Patients who received radical resection of esophageal cancer;
Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;

Exclusion Criteria:

Patients who received upper gastrointestinal surgeries;
Patients with second primary tumors;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiying Yang	Contact	0086-10-62680809		celineyang@linkdoc.com
Chunya Chen	Contact	0086-10-62680809		violazhang@linkdoc.com

Overall Officials

Name	Affiliation	Role
Yin Li	Henan Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100029	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided