Prediction Model of Response for CCRT in Esophageal Cancer

Recruiting

• Conditions: Esophageal Cancer
• Interventions: Other: chemoradiotherapy

• Registration Number: NCT03081988
• Lead Sponsor: Kyungpook National University Hospital

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

Study Timeline

• Study Start: 2015-10-19
• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-03-11
• Study First Posted: 2017-03-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Responder	chemoradiotherapy	Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT
non-responder	chemoradiotherapy	Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT

Primary Outcome Measures

Name	Time	Method
Prediction model for CCRT response based on clinical and genetic molecular factors	up to 36 months	prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer

Secondary Outcome Measures

Name	Time	Method
banking of remained human material for post genetic & molecular study	up to 10 years	banking of remained human material for post genetic \& molecular study
tissue prediction marker for CCRT response and prognosis	up to 5 years	tissue RNA sequencing / tissue microarray
circulating preditction marker for CCRT response and prognosis	up to 5 years	circulating miRNA sequencing
in-vitro prediction of CCRT using primary esophageal cancer organoid	up to 6 month	1. 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.

Trial Locations

Locations (1)

Kyungpook National University Medical Canter; 🇰🇷 Daegu, Korea, Republic of