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Retrospective review of old patients
Prospective case-control study: RNA sequencing & miRNA microarray
naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy
***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.
Retrospective review of old patients
Study Group
Prospective case-control study: RNA sequencing & miRNA microarray
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
4) TMA for screened exon gene
5) validation set for qPCR (esophageal tissue) new esophageal cancer set
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
8) Validate the prediction model.
9) primary organoid culture and prediction of chemoradiotherapy response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Responder | Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT |
| |
| non-responder | Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoradiotherapy | Other | concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical prediction factors for CCRT response (retrospective study) | Evaluation of clinical prediction factors for CCRT response in esophageal cancer from 2005-2015 (retrospective study) | up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su Youn Y Nam, MD, PhD | Contact | 82-53-200-2610 | nam20131114@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Youn Nam, MD, PhD | Kyungpook National University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Medical Canter | Recruiting | Daegu | 41404 | South Korea |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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esophageal cancer tissue and paired normal tissue serum, plasma, buffy coat (DNA), whole blood (RNA)
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 |
| up to 6 month |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |