Prediction Model of Response for CCRT in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03081988
• Other study ID #: 2015R1D1A1A01059219
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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