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RecruitingNCT03253107Updated Oct 4, 2023

Predicting Biomarker of Gastric Cancer Chemotherapy Response

An observational study in Gastric Cancer, Chemotherapy Effect and Predictive Cancer Model, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Kyungpook National University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
800
Ages
20 Years to 80 Years
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Gastric Cancer
  • Chemotherapy Effect
  • Predictive Cancer Model

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Keywords

  • gastric cancer
  • RNA sequencing
  • chemotherapy response
  • miRNA sequencing
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • patients who refused the study.
  • patients who have other cancers
  • heavy alcoholics
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • responder in palliative chemotherapy

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

    Drug: Chemotherapy

  • non-responder in palliative chemotherapy

    After initial chemotherapy, disease progression

    Drug: Chemotherapy

  • responder in adjuvant chemotherapy

    complete cure and no recurrence at least 1 year after treatment

    Drug: Chemotherapy

  • non-responder in adjuvant chemotherapy

    non-complete cure or recurrence within 1 year after treatment

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

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

    Also known as: XP or Xelox +/- Herceptin

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 36 months

Secondary outcomes

  1. 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

    Time frame: up to 5 years

  2. 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

    Time frame: up to 3 years

06

Study locations

1 of 1 sites recruiting
  • Kyungpook National University Medical Canter
    Daegu, 41404, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03253107
Lead sponsor
Kyungpook National University Hospital
Responsible party
Su Youn Nam (Professor, Kyungpook National University Chilgok Hospital) — Principal investigator
First posted
Aug 17, 2017
Start date
Nov 30, 2015
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 4, 2023

Study contacts

Su Youn Nam, MD, PhD
Contact
nam20131114@gmail.com
82-53-200-2610
Su Youn Nam, MD, PhD
principal investigator · Kyungpook National University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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