Predicting Biomarker of Gastric Cancer Chemotherapy Response

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03253107

Collaborator

(none)

800

Enrollment

Location

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Chemotherapy Effect Predictive Cancer Model	Drug: Chemotherapy

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)

response group
progression group

Post-OP adjuvant chemotherapy

institutional primary Chemotherapy regimen

complete response group
non-responder group
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

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 30, 2015

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
responder in palliative chemotherapy After initial chemotherapy, responder (complete remission, partial remission)	Drug: Chemotherapy Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin Other Names: XP or Xelox +/- Herceptin
non-responder in palliative chemotherapy After initial chemotherapy, disease progression	Drug: Chemotherapy Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin Other Names: XP or Xelox +/- Herceptin
responder in adjuvant chemotherapy complete cure and no recurrence at least 1 year after treatment	Drug: Chemotherapy Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin Other Names: XP or Xelox +/- Herceptin
non-responder in adjuvant chemotherapy non-complete cure or recurrence within 1 year after treatment	Drug: Chemotherapy Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin Other Names: XP or Xelox +/- Herceptin

Outcome Measures

Primary Outcome Measures

Discovery of predicting bio-markers for gastric cancer chemotherapy response [up to 36 months]
Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR

Secondary Outcome Measures

Combination prediction model for adjuvant chemotherapy response in gastric cancer [up to 5 years]
Combination 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 cancer [up to 3 years]
Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Medical Canter	Daegu		Korea, Republic of	41404

Sponsors and Collaborators

Kyungpook National University Hospital

Investigators

Principal Investigator: Su Youn Nam, MD, PhD, Kyungpook National University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Su Youn Nam, Professor, Kyungpook National University Chilgok Hospital

ClinicalTrials.gov Identifier:

NCT03253107

Other Study ID Numbers:

KNUMC 2015-10-002-004

First Posted:

Aug 17, 2017

Last Update Posted:

Aug 16, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Su Youn Nam, Professor, Kyungpook National University Chilgok Hospital

gastric cancer

RNA sequencing

chemotherapy response

miRNA sequencing

Additional relevant MeSH terms:

Stomach Neoplasms

Trastuzumab

Study Results

No Results Posted as of Aug 16, 2021