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The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan

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clinicaltrials.gov/study/NCT04996095
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT049960950
Health Conditions in Trial
Esophageal cancer
Esophageal cancer
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Trial Recruitment Size
4000
Trial Collaborator
National Taiwan University Hospital
National Taiwan University Hospital
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Clinical Trial Start Date
October 1, 2021
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Primary Completion Date
December 31, 2029
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Study Completion Date
December 31, 2029
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Official Name
The Registry Study of Genetic Alterations of Esophageal Cancer in Taiwan0
Last Updated
November 22, 2023
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Study summary

Protocol Objectives Establish a platform for sharing integrated database of genetic background, clinical information, and therapeutic outcomes in locally advanced and recurrent/metastatic ESCC. To enroll a total of 400 ESCC patients with different ages and stages according to the eligibility criteria defined in section 5 and section 6.To perform NGS analysis of ESCC tumor tissues, and correlated with the clinical characteristics and treatment outcomes of ESCC patients.To compare the difference of the genetic and molecular profiles among different age groups of ESCC patients.To reveal the evolution changes of genetic and molecular profiles of ESCC by comparing the difference of genetic and molecular alterations between primary and recurrent ESCC and between locally advanced and metastatic ESCC. 。 Study Method, Procedures, and Implementation Status Sample size: 400 patients with ESCC who fit inclusion criteria and exclusion criteria listed in session 6 of the study proposal. 1. To meet the study object of investigating "the difference of the genetic and molecular profiles among different age groups", a minimum of 75 young ESCC patients (with age of ESCC diagnosis at 20-45 years old) and a minimum of 75 elderly ESCC patients (with age of ESCC diagnosis at ≥ 75 years old) will be recruited. 2. To meet the study object of investigating "the evolution changes of genetic and molecular profiles of ESCC", an approximate of 100 recurrent or metastatic ESCC tumors will be included. Centralized Planning Unit and Assisting Unit: Taiwan Cooperative Oncology Group (TCOG), National Health Research Institutes

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