Predicting Biomarker of Gastric Cancer Chemotherapy Response

NCT ID: NCT03253107

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2024-12-31

Brief Summary

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* 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

Detailed Description

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* 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

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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

Conditions

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Gastric Cancer Chemotherapy Effect Predictive Cancer Model

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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responder in palliative chemotherapy

After initial chemotherapy, responder (complete remission, partial remission)

Chemotherapy

Intervention Type DRUG

Institutinal standard chemotherapy as first line

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

non-responder in palliative chemotherapy

After initial chemotherapy, disease progression

Chemotherapy

Intervention Type DRUG

Institutinal standard chemotherapy as first line

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

responder in adjuvant chemotherapy

complete cure and no recurrence at least 1 year after treatment

Chemotherapy

Intervention Type DRUG

Institutinal standard chemotherapy as first line

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

non-responder in adjuvant chemotherapy

non-complete cure or recurrence within 1 year after treatment

Chemotherapy

Intervention Type DRUG

Institutinal standard chemotherapy as first line

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

Interventions

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Chemotherapy

Institutinal standard chemotherapy as first line

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

Intervention Type DRUG

Other Intervention Names

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XP or Xelox +/- Herceptin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Su Youn Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Su Youn Nam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Medical Center

Locations

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Kyungpook National University Medical Canter

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Su Youn Nam, MD, PhD

Role: CONTACT

82-53-200-2610

Facility Contacts

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Su Youn Y Nam, MD, PhD

Role: primary

82-53-200-2610

Other Identifiers

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KNUMC 2015-10-002-004

Identifier Type: -

Identifier Source: org_study_id

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