Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics

January 31, 2021 updated by: Sun Ying-Shi, Peking University Cancer Hospital & Institute
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pathologically proven esophageal cancer patients who receive preoperative CT and surgical resection in our hospital.

Description

Inclusion Criteria:

  • pathologically proven esophageal cancer
  • scheduled to preoperative enhanced chest CT and undergo surgery
  • sign the patient informed consent

Exclusion Criteria:

  • failed to receive preoperative enhanced chest CT or undergo surgery
  • inavailable pathological results for local lymph node status
  • inquality of CT images for feature extraction
  • patient quit

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preoperative enhanced chest CT
The cohort contains patients with preoperative therapies and patients without preoperative therapies. Each patient receives regular preoperative enhanced chest CT; for patients with preoperative therapies, they usually undergo twice enhanced chest CT examination at before and after preoperative therapies, the CT images after preoperative therapies will be used for analysis
Procedure: preoperative enhanced chest CT examination
Each patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological local lymph node status
Time Frame: Pathologic evaluation will be performed for each patient within 1 week after surgery
pathological lymph node status is defined as lymph node metastasis exist or not
Pathologic evaluation will be performed for each patient within 1 week after surgery

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Chair: Ying-Shi Sun, MD, Dept.Radiology,Peking University Cancer Hospital

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)

February 15, 2017

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRadiomics-LMesophagus-BNSF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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