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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03081988
Enrollment
140
Registered
2017-03-17
Start date
2015-10-19
Completion date
2024-12-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer, chemoradiotherapy response, molecular factors

Brief 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

Interventions

OTHERchemoradiotherapy

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

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Prediction model for CCRT response based on clinical and genetic molecular factorsup to 36 monthsprediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer

Secondary

MeasureTime frameDescription
banking of remained human material for post genetic & molecular studyup to 10 yearsbanking of remained human material for post genetic & molecular study
circulating preditction marker for CCRT response and prognosisup to 5 yearscirculating miRNA sequencing
tissue prediction marker for CCRT response and prognosisup to 5 yearstissue RNA sequencing / tissue microarray
in-vitro prediction of CCRT using primary esophageal cancer organoidup to 6 month1. Esophageal cancer derived primary organoid culture 2. treat RT and 5-FU to esophageal cancer organoid 3. measure the response of CCRT (live cell/dead cell) * This process is in-vitro process, not in-vivo experiment.

Other

MeasureTime frameDescription
Clinical prediction factors for CCRT response (retrospective study)up to 5 yearsEvaluation of clinical prediction factors for CCRT response in esophageal cancer from 2005-2015 (retrospective study)

Countries

South Korea

Contacts

Primary ContactSu Youn Y Nam, MD, PhD
nam20131114@gmail.com82-53-200-2610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026