Predicting Biomarker of Gastric Cancer Chemotherapy Response

Kyungpook National University

Status: Enrolling

Conditions: Chemotherapy Effect; Gastric Cancer; Predictive Cancer Model

Treatments: Drug: Chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03253107

KNUMC 2015-10-002-004

Details and patient eligibility

About

• 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

Full 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

Enrollment: 800 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 4 patient groups

responder in palliative chemotherapy

Description:

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

Treatment:

Drug: Chemotherapy

non-responder in palliative chemotherapy

Description:

After initial chemotherapy, disease progression

Treatment:

Drug: Chemotherapy

responder in adjuvant chemotherapy

Description:

complete cure and no recurrence at least 1 year after treatment

Treatment:

Drug: Chemotherapy

non-responder in adjuvant chemotherapy

Description:

non-complete cure or recurrence within 1 year after treatment

Treatment:

Drug: Chemotherapy