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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02908204
Other study ID # SGZAHGX
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2016
Last updated September 19, 2016
Start date October 2016

Study information

Verified date September 2016
Source Shanghai Zhongshan Hospital
Contact Shiyao CHEN, PhD
Phone 13601767310
Email chen.shiyao@zs-hospital.sh.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma.

Exclusion Criteria:

- Combined with other severe disease

- With a history of esophageal surgery

- Combined with other malignant disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Hospital, Shanghai Shanghai

Sponsors (4)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital The affiliated Hospital of Shihezi University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 3 years after treatment No
Secondary Recurrence rate 3 years after treatment No
Secondary Short-term complications incidence rate 30 days after treatment No
Secondary Long-term complications incidence rate 3 years after treatment No
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