Determining the Optimal Examined Lymph Node for Accurate... | NCT05572151

Studies
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer

NCT05572151

Sponsor

The Second Affiliated Hospital of Harbin Medical University

Status

Completed

Last Update Posted

Oct 7, 2022Actual

Enrollment

7,694Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

lymph node number

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

Oct 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

Jan 1, 2009Actual

Primary Completion Date

Dec 10, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Oct 4, 2022

First Submission Date that Met QC Criteria

Oct 6, 2022

First Posted Date

Oct 7, 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

Oct 6, 2022

Last Update Posted Date

Oct 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shuai Jiao, Principal Investigator, The Second Affiliated Hospital of Harbin Medical UniversityPrincipal Investigator

Lead Sponsor

The Second Affiliated Hospital of Harbin Medical UniversityOTHER

Collaborators

Not provided

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

Detailed Description

A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)

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

7,694Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lymph node number	Procedure	Lymph nodes were harvested during surgical resection of rectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lymph node number	lymph nodes were harvested during surgical resection of rectal cancer	during the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible

Exclusion Criteria:

Patients with missing values on lymph node count and clinical features were excluded

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Information about patients (age, sex and year of diagnosis), tumor (TNM stages, histology, size and differentiation), treatments (resection type, chemotherapy), and outcome variables (follow-up time and survival status) were obtained in SEER database and China registry

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28542954	Background	Del Paggio JC, Peng Y, Wei X, Nanji S, MacDonald PH, Krishnan Nair C, Booth CM. Population-based study to re-evaluate optimal lymph node yield in colonic cancer. Br J Surg. 2017 Jul;104(8):1087-1096. doi: 10.1002/bjs.10540. Epub 2017 May 24.
37428195	Derived	Guan X, Jiao S, Wen R, Yu G, Liu J, Miao D, Wei R, Zhang W, Hao L, Zhou L, Lou Z, Liu S, Zhao E, Wang G, Zhang W, Wang X. Optimal examined lymph node number for accurate staging and long-term survival in rectal cancer: a population-based study. Int J Surg. 2023 Aug 1;109(8):2241-2248. doi: 10.1097/JS9.0000000000000320.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms