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Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics

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ClinicalTrials.gov Identifier: NCT03237130
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Ying-Shi, Beijing Cancer Hospital

Brief Summary:
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

Condition or disease Intervention/treatment
Esophagus Cancer Procedure: preoperative enhanced chest CT examination

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
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pathologically proven esophageal cancer patients who receive preoperative CT and surgical resection in our hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237130


Contacts
Contact: Ying-Shi Sun, MD 861088196822 sys27@163.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Ying-Shi Sun, MD    861088196822    sys27@163.com   
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Study Chair: Ying-Shi Sun, MD Dept.Radiology,Peking University Cancer Hospital

Responsible Party: Sun Ying-Shi, Chairman of Dept.Radiology of Beijing Cancer Hospital, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03237130     History of Changes
Other Study ID Numbers: CTRadiomics-LMesophagus-BNSF
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sun Ying-Shi, Beijing Cancer Hospital:
esophagus cancer; radiomics; computed tomograpy

Additional relevant MeSH terms:
Esophageal Neoplasms
Lymphatic Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes