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Predicting Biomarker of Gastric Cancer Chemotherapy Response

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03253107
Enrollment
800
Registered
2017-08-17
Start date
2015-11-30
Completion date
2024-12-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effect, Gastric Cancer, Predictive Cancer Model

Keywords

gastric cancer, RNA sequencing, chemotherapy response, miRNA sequencing

Brief 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

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

Interventions

DRUGChemotherapy

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

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Discovery of predicting bio-markers for gastric cancer chemotherapy responseup to 36 monthsDiscovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR

Secondary

MeasureTime frameDescription
Combination prediction model for adjuvant chemotherapy response in gastric cancerup to 5 yearsCombination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
Combination prediction model for palliative chemotherapy response in gastric cancerup to 3 yearsCombination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer

Countries

South Korea

Contacts

Primary ContactSu Youn Nam, MD, PhD
nam20131114@gmail.com82-53-200-2610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026