Clinical trial NCT03415815: An Observational Study to Evaluate Lymph Metastases and Prognoses of the Patients With Esophageal Cancer
Official title: A Real-world Observational Study to Evaluate Lymph Metastases and Prognoses of the Chinese Patients With Thoracic T1-T3 Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: Chinese, real-world evidences, T1-T3 esophageal cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-01-30
Enrollment: 3673
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically diagnosed Chinese patients with thoracic T1-T3 esophageal cancer who received radical resection of esophageal cancer

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

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.

Eligibility 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;

Primary outcomes:
measure: Numbers of lymph nodes and percentages of patients with surgeries
timeFrame: 1999 - 2017
Secondary outcomes:
measure: Impact factors of lymph metastases
timeFrame: 1999 - 2017
Other outcomes:
measure: Effects of lymph metastases on overall survival
timeFrame: 1999 - 2017
measure: Effects of the numbers of lymph nodes on overall survival
timeFrame: 1999 - 2017
measure: Effects of surgeries on the percentages of the patients with esophageal cancer who received lymphadenectomy
timeFrame: 1999 - 2017
measure: Effects of surgeries on the extents of the patients with esophageal cancer who received surgeries
timeFrame: 1999 - 2017
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chendu
country: China
facility: Huaxi Hospital Affiliated to Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University
state: Zhejiang
Study officials:
affiliation: Henan Cancer Hospital
name: Yin Li
role: PRINCIPAL_INVESTIGATOR
References: