Prediction Model of Response for CCRT in Esophageal Cancer
NCT ID: NCT03081988
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
140 participants
OBSERVATIONAL
2015-10-19
2024-12-31
Brief Summary
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* 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.
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Responder
Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer
evaluation of disease status: endoscopy, CT, and/or PET-CT
chemoradiotherapy
concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.
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
chemoradiotherapy
concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.
Interventions
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chemoradiotherapy
concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.
Eligibility Criteria
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Inclusion Criteria
2. persons who assigned the written informed consents.
Exclusion Criteria
2. other organ cancer
3. heavy alcoholics
40 Years
80 Years
ALL
No
Sponsors
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Kyungpook National University Hospital
OTHER
Responsible Party
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Su Youn Nam
Professor
Principal Investigators
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Su Youn Nam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Medical Center
Locations
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Kyungpook National University Medical Canter
Daegu, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015R1D1A1A01059219
Identifier Type: -
Identifier Source: org_study_id
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