Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy (NJBMR)

March 24, 2015 updated by: Satoshi Nishizuka, Iwate Medical University

Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1

Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has improved disease free time and survival. However, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. In an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by immunohistochemical validation. In the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective study. Data analyses are based on archived record and materials of gastric cancer patients whose treatment was curative surgery followed by adjuvant chemotherapy with S-1.

Description

Inclusion Criteria:

  • Pathologically confirmed gastric cancer.
  • Operated before November 2009.
  • Stage Ib/II(except for T1, T3N0)/III.
  • Received postoperative (R0) adjuvant chemotherapy (S-1).
  • Not received postoperative (R0) adjuvant chemotherapy (surgery alone).
  • Signed informed consent to provide paraffin embedded tissue of removed specimens.

Exclusion Criteria:

  • With advanced neoplastic lesions other than gastric cancer.
  • Paraffin embedded tissue is not available.
  • Unknown S-1 treatment condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biomarker positive
NF-kB(+)/JNK(-) in curatively removed specimens
Biomarker negative
NF-kB(-)/JNK(+) in curatively removed specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse free survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iwate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (ESTIMATE)

July 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIAST-NJBMR-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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