An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer

A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer

The real-world observational study was designed to explore lymph metastases and prognoses of the Chinese patients with thoracic T1-T3 esophageal cancer

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Surgeries

Detailed Description

This trial is a real-world non-interventional observational study. The Chinese patients with thoracic T1-T3 esophageal cancer enrolled from Jan.1999 to Jun.2017 were included and the study data on pathologically diagnosed patient demographic/tumor biological characteristics were collected to evaluate the relevance of lymph metastases and prognoses of the subjects.

• Study Type: Observational
• Enrollment (Anticipated): 3673

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Deruo Liu, PhD
    • Beijing, Beijing, China, 100853
      • Recruiting
      • China PLA General Hospital
      • Contact: Yang Liu, PhD
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Yin Li, PhD
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital Affiliated to Huazhong Technology Hospital
      • Contact: Yin Li, PhD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Hospital
      • Contact: Lin Xu, PhD
  • Shaanxi
    • Xi'an, Shaanxi, China, 610041
      • Recruiting
      • Xi'an Tangdu Hospital
      • Contact: Xiaofei Li, PhD
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Heng Zhao, PhD
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • Recruiting
      • Huaxi Hospital Affiliated to Sichuan University
      • Contact: Lunxu Liu, PhD
  • Tianjin
    • Tianjin, Tianjin, China, 300051
      • Recruiting
      • Tianjin Chest Hospital
      • Contact: Xun Zhang, PhD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • First Hospital Affiliated to Zhejiang University
      • Contact: Jian Hu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer

Description

Inclusion Criteria:

• Patients >= 18 years old;
• Patients who received radical resection of esophageal cancer;
• Pathologically diagnosed patients with thoracic T1-T3 esophageal cancer after surgeries;

Exclusion Criteria:

• Patients who received upper gastrointestinal surgeries;
• Patients with second primary tumors;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T1-T3 esophageal cancer; Pathologically diagnosed patients with T1-T3 esophageal cancer who received surgeries	Procedure: Surgeries; Radical resection of esophageal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of lymph nodes and percentages of patients with surgeries	Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer	1999 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact factors of lymph metastases	Impact factors of lymph metastases	1999 - 2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of lymph metastases on overall survival	Effects on lymph metastases on overall survival in the patients with thoracic esophageal cancer	1999 - 2017
Effects of the numbers of lymph nodes on overall survival	Effects of the numbers of lymph nodes on overall survival in the patients with thoracic esophageal cancer who received lymphadenectomy	1999 - 2017
Effects of surgeries on the percentages of the patients with esophageal cancer who received lymphadenectomy	Effects of surgeries on the percentages of the thoracic T1-T3 patients with esophageal cancer who received lymphadenectomy	1999 - 2017
Effects of surgeries on the extents of the patients with esophageal cancer who received surgeries	Effects of surgeries on the extents of the thoracic T1-T3 patients with esophageal cancer who received surgeries	1999 - 2017

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Yin Li, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): April 30, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Chinese, real-world evidences, T1-T3 esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: HenanEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No