Prediction Model of Response for CCRT in Esophageal Cancer

Kyungpook National University

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Other: chemoradiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03081988

2015R1D1A1A01059219

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 2 patient groups

Responder

Description:

Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT

Treatment:

Other: chemoradiotherapy

non-responder

Description:

Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT

Treatment:

Other: chemoradiotherapy