Prediction Model of Response for CCRT in Esophageal Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: chemoradiotherapy

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

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Su Youn Y Nam, MD, PhD; Phone Number: 82-53-200-2610; Email: nam20131114@gmail.com

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Recruiting
    • Kyungpook National University Medical Canter
    • Contact: Su Youn Y Nam, MD, PhD; Phone Number: 82-53-200-2610; Email: nam20131114@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responder; Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT	Other: 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	Other: chemoradiotherapy; concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Principal Investigator: Su Youn Nam, MD, PhD, Kyungpook National University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2015
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: March 11, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Esophageal Cancer; molecular factors; chemoradiotherapy response
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2015R1D1A1A01059219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No