Prediction Model of Response for CCRT in Esophageal Cancer

Status Recruiting

Clinical Trial Summary

1. Retrospective review of old patients - Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 2. Prospective case-control study: RNA sequencing & miRNA microarray - naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy - acquirement of tissue, blood, clinical information - isolation of RNA, DNA, serum database of clinical & demographic information ***Analysis of mRNA sequencing / miRNA sequencing**** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator 3. Experimental set for qPCR (esophageal tissue) study group 4. TMA for screened exon gene 5. validation set for qPCR (esophageal tissue) 6. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M) 7. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors 8. Validate the prediction model.

Clinical Trial Description

1. Retrospective review of old patients - Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 Study Group 1. non responder 2. CR but recurrence 3. CR and survival loner than 2 years 2. Prospective case-control study: RNA sequencing & miRNA microarray - naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy --> acquirement of tissue, blood, clinical information --> isolation of RNA, DNA, serum database of clinical & demographic information study group 1. non-responder (N=14) 2. Complete Remission (N=14) For considering the drop rate, 2-fold screening ***Analysis of mRNA sequencing / miRNA sequencing**** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator 3) Experimental set for qPCR (esophageal tissue) study group 1. non-responder (N=40) 2. complete remission (N=40) 4) TMA for screened exon gene 5) validation set for qPCR (esophageal tissue) new esophageal cancer set 1. non-responder (N=30) 2. complete remission (N=30) 6) follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M) 7) Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors Test several combination models 1. gene + gene combination, 2. gene + clinical information combination, 3. gene + gene + clinical information combination 8) Validate the prediction model. 9) primary organoid culture and prediction of chemoradiotherapy response ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03081988
Study type	Observational [Patient Registry]
Source	Kyungpook National University Hospital
Contact	Su Youn Y Nam, MD, PhD
Phone	82-53-200-2610
Email	nam20131114@gmail.com
Status	Recruiting
Phase
Start date	October 19, 2015
Completion date	December 31, 2024

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