Prediction Model of Response for CCRT in Esophageal Cancer

Esophageal Cancer Clinical Trial

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

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 ;

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

• 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
• Start date: October 19, 2015
• Completion date: December 31, 2024