NCT03081988

Prediction Model of Response for CCRT in Esophageal Cancer

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: —

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.

Detailed 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

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
OTHER	chemoradiotherapy	concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.

Timeline

• Start date: 2015-10-19
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2017-03-17
• Last updated: 2023-10-04

Locations

1 site across 1 country: South Korea