Predicting Biomarker of Gastric Cancer Chemotherapy Response
NCT ID: NCT03253107
Last Updated: 2023-10-04
Study Results
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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UNKNOWN
800 participants
OBSERVATIONAL
2015-11-30
2024-12-31
Brief Summary
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* 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
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Detailed Description
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* 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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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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responder in palliative chemotherapy
After initial chemotherapy, responder (complete remission, partial remission)
Chemotherapy
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who agreed this study and voluntarily assigned the informed consents.
Exclusion Criteria
* patients who have other cancers
* heavy alcoholics
20 Years
80 Years
ALL
No
Sponsors
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Kyungpook National University Hospital
OTHER
Responsible Party
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Su Youn Nam
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KNUMC 2015-10-002-004
Identifier Type: -
Identifier Source: org_study_id
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