Clinical trial NCT03081988: Prediction Model of Response for CCRT in Esophageal Cancer
Official title: Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
chemoradiotherapy response
molecular factors
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy

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

Eligibility criteria: 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

Primary outcomes:
measure: Prediction model for CCRT response based on clinical and genetic molecular factors
timeFrame: up to 36 months
Secondary outcomes:
measure: banking of remained human material for post genetic & molecular study
timeFrame: up to 10 years
measure: circulating preditction marker for CCRT response and prognosis
timeFrame: up to 5 years
measure: tissue prediction marker for CCRT response and prognosis
timeFrame: up to 5 years
measure: in-vitro prediction of CCRT using primary esophageal cancer organoid
timeFrame: up to 6 month
Other outcomes:
measure: Clinical prediction factors for CCRT response (retrospective study)
timeFrame: up to 5 years
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Canter
Study officials:
affiliation: Kyungpook National University Medical Center
name: Su Youn Nam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: