Clincosm LogoSign in Get a demo

Prediction Model of Response for CCRT in Esophageal Cancer

Sponsor
Kyungpook National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03081988
Collaborator
(none)
140
Enrollment
1
Location
86.4
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
  1. 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

  1. Experimental set for qPCR (esophageal tissue) study group

  2. TMA for screened exon gene

  3. validation set for qPCR (esophageal tissue)

  4. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M)

  5. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors

  6. Validate the prediction model.

Condition or Disease Intervention/Treatment Phase
  • Other: chemoradiotherapy

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

  4. 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

  1. non-responder (N=40)

  2. complete remission (N=40)

  1. TMA for screened exon gene

  2. validation set for qPCR (esophageal tissue) new esophageal cancer set

  1. non-responder (N=30)

  2. complete remission (N=30)

  1. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M)

  2. 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.

  2. primary organoid culture and prediction of chemoradiotherapy response

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology
Actual Study Start Date :
Oct 19, 2015
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Responder

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. banking of remained human material for post genetic & molecular study [up to 10 years]

    banking of remained human material for post genetic & molecular study

  2. circulating preditction marker for CCRT response and prognosis [up to 5 years]

    circulating miRNA sequencing

  3. tissue prediction marker for CCRT response and prognosis [up to 5 years]

    tissue RNA sequencing / tissue microarray

  4. in-vitro prediction of CCRT using primary esophageal cancer organoid [up to 6 month]

    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.

Other Outcome Measures

  1. Clinical prediction factors for CCRT response (retrospective study) [up to 5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyungpook National University Medical Canter Daegu Korea, Republic of 41404

Sponsors and Collaborators

  • Kyungpook National University Hospital

Investigators

  • Principal Investigator: Su Youn Nam, MD, PhD, Kyungpook National University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Su Youn Nam, Professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier:
NCT03081988
Other Study ID Numbers:
  • 2015R1D1A1A01059219
First Posted:
Mar 17, 2017
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Su Youn Nam, Professor, Kyungpook National University Hospital
Esophageal Cancer
chemoradiotherapy response
molecular factors
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Aug 10, 2021