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RecruitingNCT03081988Updated Oct 4, 2023

Prediction Model of Response for CCRT in Esophageal Cancer

An observational study in Esophageal Cancer, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Kyungpook National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2015; still recruiting 11 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
40 Years to 80 Years
Sex
All
01

Study 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.
Read the 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

    1. Experimental set for qPCR (esophageal tissue) study group
    2. non-responder (N=40)
    3. complete remission (N=40)
    1. TMA for screened exon gene
    1. validation set for qPCR (esophageal tissue) new esophageal cancer set
    2. non-responder (N=30)
    3. complete remission (N=30)
    1. follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
    1. 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
    1. Validate the prediction model.
    1. primary organoid culture and prediction of chemoradiotherapy response
02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal Cancer
  • chemoradiotherapy response
  • molecular factors
03

In context

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

This study's planned enrollment of 140 is below the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
  2. persons who assigned the written informed consents.

Exclusion criteria

Exclusion Criteria:

  1. persons who did't assign the informed consents
  2. other organ cancer
  3. heavy alcoholics
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Responder

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

    Other: chemoradiotherapy

  • 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

Interventions

  • Otherchemoradiotherapy

    concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 36 months

Secondary outcomes

  1. banking of remained human material for post genetic & molecular study

    banking of remained human material for post genetic \& molecular study

    Time frame: up to 10 years

  2. circulating preditction marker for CCRT response and prognosis

    circulating miRNA sequencing

    Time frame: up to 5 years

  3. tissue prediction marker for CCRT response and prognosis

    tissue RNA sequencing / tissue microarray

    Time frame: up to 5 years

  4. in-vitro prediction of CCRT using primary esophageal cancer organoid

    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.

    Time frame: up to 6 month

Other outcomes

  1. Clinical prediction factors for CCRT response (retrospective study)

    Evaluation of clinical prediction factors for CCRT response in esophageal cancer from 2005-2015 (retrospective study)

    Time frame: up to 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03081988
Lead sponsor
Kyungpook National University Hospital
Responsible party
Su Youn Nam (Professor, Kyungpook National University Hospital) — Principal investigator
First posted
Mar 17, 2017
Start date
Oct 19, 2015
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 4, 2023

Study contacts

Su Youn Y Nam, MD, PhD
Contact
nam20131114@gmail.com
82-53-200-2610
Su Youn Nam, MD, PhD
principal investigator · Kyungpook National University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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