Predicting Biomarker of Gastric Cancer Chemotherapy Response

October 3, 2023 updated by: Su Youn Nam, Kyungpook National University Hospital

Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response

  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

    • Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
    • Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
    • Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
  • Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

    • Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)

      • institutional primary Chemotherapy regimen (XP or Xelox)

        1. response group

        2. progression group

          Post-OP adjuvant chemotherapy

      • institutional primary Chemotherapy regimen

        1. complete response group
        2. non-responder group
        1. and 2) groups: age, sex, regimen matched

    • Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group

      • the same patients in mRNA sequencing
    • Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
  • Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Medical Canter
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

<Next generation sequencing analysis> (A) palliative chemotherapy

  1. responder (n=15)
  2. progression (n=15)

(B) adjuvant chemotherpay

  1. complete response (n=15)
  2. non-responder (n=15)

<qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy

  1. responder (n=60)
  2. progression (n=60)

(B) adjuvant chemotherpay

  1. complete responder (n=60)
  2. non-responder (n=60)

(Validation set) (A) palliative chemotherapy

  1. responder (n=40)
  2. progression (n=40)

(B) adjuvant chemotherpay

  1. complete responder (n=40)
  2. non-responder (n=40)

1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.

Description

Inclusion Criteria:

  • new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
  • patients who agreed this study and voluntarily assigned the informed consents.

Exclusion Criteria:

  • patients who refused the study.
  • patients who have other cancers
  • heavy alcoholics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
responder in palliative chemotherapy
After initial chemotherapy, responder (complete remission, partial remission)
Drug: Chemotherapy

Institutinal standard chemotherapy as first line

: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

Other Names:
  • XP or Xelox +/- Herceptin
non-responder in palliative chemotherapy
After initial chemotherapy, disease progression
Drug: Chemotherapy

Institutinal standard chemotherapy as first line

: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

Other Names:
  • XP or Xelox +/- Herceptin
responder in adjuvant chemotherapy
complete cure and no recurrence at least 1 year after treatment
Drug: Chemotherapy

Institutinal standard chemotherapy as first line

: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

Other Names:
  • XP or Xelox +/- Herceptin
non-responder in adjuvant chemotherapy
non-complete cure or recurrence within 1 year after treatment
Drug: Chemotherapy

Institutinal standard chemotherapy as first line

: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

Other Names:
  • XP or Xelox +/- Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovery of predicting bio-markers for gastric cancer chemotherapy response
Time Frame: up to 36 months
Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combination prediction model for adjuvant chemotherapy response in gastric cancer
Time Frame: up to 5 years
Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
up to 5 years
Combination prediction model for palliative chemotherapy response in gastric cancer
Time Frame: up to 3 years
Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUMC 2015-10-002-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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