Predicting Biomarker of Gastric Cancer Chemotherapy Response

NCT03253107 | Unknown DMC

• 1 other identifier: KNUMC 2015-10-002-004
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer; Chemotherapy Effect; Predictive Cancer Model

Keywords

gastric cancer; RNA sequencing; chemotherapy response; miRNA sequencing

Outcome Measures

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

  up to 36 months

Secondary Outcomes (2)

• Combination prediction model for adjuvant chemotherapy response in gastric cancer

  up to 5 years

• Combination prediction model for palliative chemotherapy response in gastric cancer

  up to 3 years

Study Arms (4)

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

Chemotherapy DRUG

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

Also known as: XP or Xelox +/- Herceptin

non-responder in adjuvant chemotherapy; non-responder in palliative chemotherapy; responder in adjuvant chemotherapy; responder in palliative chemotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
• patients who agreed this study and voluntarily assigned the informed consents.

You may not qualify if:

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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Medical Canter

Daegu, 41404, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

RNA from gastric tissue and blood DNA from blood

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Su Youn Nam, MD, PhD

  Kyungpook National University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Su Youn Nam, MD, PhD

CONTACT

82-53-200-2610; nam20131114@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: November 30, 2015
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

KR (1)