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

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ClinicalTrials.gov Identifier: NCT03415815
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
Yin Li, Henan Cancer Hospital

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

Condition or disease Intervention/treatment
Esophageal Cancer 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
Estimated Enrollment : 3673 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Numbers of lymph nodes and percentages of patients with surgeries [ Time Frame: 1999 - 2017 ]
    Numbers of lymph nodes and percentages of patients with surgeries in the patients with thoracic T1-T3 esophageal cancer


Secondary Outcome Measures :
  1. Impact factors of lymph metastases [ Time Frame: 1999 - 2017 ]
    Impact factors of lymph metastases


Other Outcome Measures:
  1. Effects of lymph metastases on overall survival [ Time Frame: 1999 - 2017 ]
    Effects on lymph metastases on overall survival in the patients with thoracic esophageal cancer

  2. Effects of the numbers of lymph nodes on overall survival [ Time Frame: 1999 - 2017 ]
    Effects of the numbers of lymph nodes on overall survival in the patients with thoracic esophageal cancer who received lymphadenectomy

  3. Effects of surgeries on the percentages of the patients with esophageal cancer who received lymphadenectomy [ Time Frame: 1999 - 2017 ]
    Effects of surgeries on the percentages of the thoracic T1-T3 patients with esophageal cancer who received lymphadenectomy

  4. Effects of surgeries on the extents of the patients with esophageal cancer who received surgeries [ Time Frame: 1999 - 2017 ]
    Effects of surgeries on the extents of the thoracic T1-T3 patients with esophageal cancer who received surgeries



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer
Criteria

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;

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): NCT03415815


Contacts
Contact: Haiying Yang 0086-10-62680809 celineyang@linkdoc.com
Contact: Chunya Chen 0086-10-62680809 violazhang@linkdoc.com

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

Responsible Party: Yin Li, Professor, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03415815     History of Changes
Other Study ID Numbers: HenanEC
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Yin Li, Henan Cancer Hospital:
Chinese, real-world evidences, T1-T3 esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases