Mapping of Lymph Node Metastasis and Survival For pN+ Sup... | NCT05526456

Studies
Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma

NCT05526456

Sponsor

National Cancer Center, China

Status

Completed

Last Update Posted

Sep 2, 2022Actual

Enrollment

207Actual

Phase

Not provided

Conditions

National Cancer Center/Cancer Hospital

Interventions

Esophagectomy

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2012Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

May 15, 2022Actual

First Submitted Date

Aug 31, 2022

First Submission Date that Met QC Criteria

Aug 31, 2022

First Posted Date

Sep 2, 2022Actual

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

Aug 31, 2022

Last Update Posted Date

Sep 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yin Li, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Cancer Center, ChinaPrincipal Investigator

Lead Sponsor

National Cancer Center, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

207Actual

Name	Type	Description	Arm Group Labels	Other Names
Esophagectomy	Procedure	McKeown, Ivor-Lewis, and Sweet procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LNM rates of the 207 thoracic T1N+ ESCC patients.		2012.2-2022.4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.

Exclusion Criteria:

The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

44 Years

Maximum Age

73 Years

Standard Ages

AdultOlder Adult

Study Population

Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D016629	Esophagectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided