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

October 6, 2022 updated by: Shuai Jiao, The Second Affiliated Hospital of Harbin Medical University

Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer: a Population Study of the US Database and a Chinese Multi-institutional Registry

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

7694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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