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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03081988
Other study ID # 2015R1D1A1A01059219
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 19, 2015
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Kyungpook National University Hospital
Contact Su Youn Y Nam, MD, PhD
Phone 82-53-200-2610
Email nam20131114@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: 1. locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy 2. persons who assigned the written informed consents. Exclusion Criteria: 1. persons who did't assign the informed consents 2. other organ cancer 3. heavy alcoholics

Study Design


Related Conditions & MeSH terms


Intervention

Other:
chemoradiotherapy
concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.

Locations

Country Name City State
Korea, Republic of Kyungpook National University Medical Canter Daegu

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 banking of remained human material for post genetic & molecular study banking of remained human material for post genetic & molecular study up to 10 years
Secondary circulating preditction marker for CCRT response and prognosis circulating miRNA sequencing up to 5 years
Secondary tissue prediction marker for CCRT response and prognosis tissue RNA sequencing / tissue microarray up to 5 years
Secondary 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
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