Prediction Model of Response for CCRT in Esophageal Cancer

Study Overview
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Brief Summary
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Retrospective review of old patients Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 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 Experimental set for qPCR (esophageal tissue) study group TMA for screened exon gene validation set for qPCR (esophageal tissue) follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M) Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors Validate the prediction model.

Detailed Description
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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 non responder CR but recurrence CR and survival loner than 2 years 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 non-responder (N=14) 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 non-responder (N=40) complete remission (N=40) 4) TMA for screened exon gene 5) validation set for qPCR (esophageal tissue) new esophageal cancer set non-responder (N=30) 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 gene + gene combination, gene + clinical information combination, gene + gene + clinical information combination 8) Validate the prediction model. 9) primary organoid culture and prediction of chemoradiotherapy response

Official Title
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Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy persons who assigned the written informed consents. Exclusion Criteria: persons who did't assign the informed consents other organ cancer heavy alcoholics

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Responder<br>Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT | Other: chemoradiotherapy<br>* concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.<br>|
| non-responder<br>Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT | Other: chemoradiotherapy<br>* concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction model for CCRT response based on clinical and genetic molecular factors | prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| banking of remained human material for post genetic & molecular study | banking of remained human material for post genetic & molecular study | up to 10 years | 
| circulating preditction marker for CCRT response and prognosis | circulating miRNA sequencing | up to 5 years | 
| tissue prediction marker for CCRT response and prognosis | tissue RNA sequencing / tissue microarray | up to 5 years | 
| in-vitro prediction of CCRT using primary esophageal cancer organoid | Esophageal cancer derived primary organoid culture treat RT and 5-FU to esophageal cancer organoid measure the response of CCRT (live cell/dead cell) This process is in-vitro process, not in-vivo experiment. | up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, chemoradiotherapy response, molecular factors