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Esophageal Cancer Risk Identification Based on Opportunistic Screening（ECRIOS） (ECRIOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04609813
Recruitment Status : Not yet recruiting
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Study Description
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Brief Summary:
This multicenter study aims to include 20000 upper gastrointestinal endoscopy and establish a risk prediction model for esophageal cancer. This study will propose a table, including Risk factors for esophageal cancer and evaluate the function and value of new type esophageal cell collector to China's esophageal cancer screening. The primary study outcome is the sensitivity and specificity of the model to diagnose esophageal cancer. Secondary outcomes include sensitivity and specificity of the esophageal cytology to diagnose esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Risk Identification Opportunistic Screening Procedure: sample collection Other: Training Not Applicable

Detailed Description:

Esophageal cancer is one of the most unknown and deadiest cancers worldwide, mainly because of its extremely aggressive nature and poor survival rate. In 2018, the incidence rate and mortality rate of esophageal cancer were 6.3/100000 and 5.5/100000. There are clear differences between the risk factors of both histological types that affect their incidence and distribution worldwide.There are areas of high incidence of squamous cell carcinoma (some areas in China) that meet the requirements for cost-effectiveness of endoscopy for early diagnosis in the general population of those areas. The gold standard to detect and diagnose esophageal cancer is upper gastrointestinal endoscopy with biopsy. However, China is a country with large population, which makes it difficult to perform screening endoscopy in the whole crowd. There are several researches showing that there is a low detecting rate of esophageal cancer if only perform screening endoscopy in high risk area. This multicenter study aims to propose a table, including Risk factors for esophageal cancer.

Besides, esophageal cytology is essential to detect and diagnose esophageal. Now there are improved esophageal cell collector（CytospongeTM、EsophaCapTM）which adopt an inflatable sponge capsule design to increase the contact area with the esophageal mucosa. Our study aims to evaluate the function and value of new type esophageal cell collector to China's esophageal cancer screening.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Esophageal Cancer Risk Identification Based on Opportunistic Screening（ECRIOS）：a Multicenter Nationalwide Study
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cytology sample collection
A nurse who has received related operation training uses the Shikang No. 1 collection device to collect cytology samples.
 Procedure: sample collection
Under the guidance of outpatient doctors, nurses or hospital staff who have received uniform training use the Shikang No. 1 collection device to collect cytology samples

Other: Training
training


Outcome Measures
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Primary Outcome Measures :
  1. the sensitivity and specificity of the model to diagnose esophageal cancer. [ Time Frame: two months ]
    the sensitivity and specificity of the risk prediction model for esophageal cancer model to diagnose esophageal cancer.


Secondary Outcome Measures :
  1. sensitivity and specificity of the esophageal cytology to diagnose esophageal cancer. [ Time Frame: two months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects that have an opportunity screening endoscopy

Exclusion Criteria:

  • subjects with difficulty swallowing, hematemesis, melena
  • subjects performed endoscopy in 1 year
  • subjects with esophageal neoplasia
  • subjects with ssophagus-gastric varices or esophageal stenosis
  • subjects with a history of esophagus or stomach surgery
  • subjects with coagulation dysfunction
  • subjects with contraindications for endoscopy or biopsy
  • subjects with other serious disease
  • subjects that refuse to cooperate with data collection or sign the informed consent
Contacts and Locations
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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): NCT04609813


Contacts
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Contact: Lei Xin 13817318134 aip_xin@163.com

Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Ye Gao Changhai Hospital
More Information
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Responsible Party: Zhaoshen Li, Director of Gastroenterology, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04609813    
Other Study ID Numbers: esophageal cancer risk
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases