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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyungpook National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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