Clinical trial NCT03253107: Predicting Biomarker of Gastric Cancer Chemotherapy Response
Official title: Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Chemotherapy Effect
Predictive Cancer Model
Keywords: gastric cancer
RNA sequencing
chemotherapy response
miRNA sequencing
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: \<Next generation sequencing analysis\> (A) palliative chemotherapy

1. responder (n=15)
2. progression (n=15)

(B) adjuvant chemotherpay

1. complete response (n=15)
2. non-responder (n=15)

\<qRT-PCR analysis\> (Experimental set) (A) palliative chemotherapy

1. responder (n=60)
2. progression (n=60)

(B) adjuvant chemotherpay

1. complete responder (n=60)
2. non-responder (n=60)

(Validation set) (A) palliative chemotherapy

1. responder (n=40)
2. progression (n=40)

(B) adjuvant chemotherpay

1. complete responder (n=40)
2. non-responder (n=40)

1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.

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

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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

Eligibility criteria: 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

Primary outcomes:
measure: Discovery of predicting bio-markers for gastric cancer chemotherapy response
timeFrame: up to 36 months
Secondary outcomes:
measure: Combination prediction model for adjuvant chemotherapy response in gastric cancer
timeFrame: up to 5 years
measure: Combination prediction model for palliative chemotherapy response in gastric cancer
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Canter
Study officials:
affiliation: Kyungpook National University Medical Center
name: Su Youn Nam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: