Predicting Biomarker of Gastric Cancer Chemotherapy Response

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253107
• Other study ID #: KNUMC 2015-10-002-004
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Gastric Cancer
• Predictive Cancer Model
• Stomach Neoplasms

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