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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03253107
Other study ID # KNUMC 2015-10-002-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2015
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Kyungpook National University Hospital
Contact Su Youn Nam, MD, PhD
Phone 82-53-200-2610
Email nam20131114@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Intervention

Drug:
Chemotherapy
Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

Locations

Country Name City State
Korea, Republic of Kyungpook National University Medical Canter Daegu

Sponsors (1)

Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Discovery of predicting bio-markers for gastric cancer chemotherapy response Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR up to 36 months
Secondary Combination prediction model for adjuvant chemotherapy response in gastric cancer Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer up to 5 years
Secondary Combination prediction model for palliative chemotherapy response in gastric cancer Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer up to 3 years
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