Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma

Esophageal Neoplasms Clinical Trial

Official title:

Long-term Outcomes After Treatment for Superficial Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908204
• Other study ID #: SGZAHGX
• 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. 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

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms

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