NCT03237130

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

July 31, 2017

Last Update Submit

January 31, 2021

Conditions

Keywords

esophagus cancer; radiomics; computed tomograpy

Outcome Measures

Primary Outcomes (1)

  • pathological local lymph node status

    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

Study Arms (1)

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

Interventions

Each patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis

preoperative enhanced chest CT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Ying-Shi Sun, MD

    Dept.Radiology,Peking University Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Dept.Radiology of Beijing Cancer Hospital

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 2, 2017

Study Start

February 15, 2017

Primary Completion

November 7, 2019

Study Completion

May 15, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations