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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01905969
Recruitment Status : Unknown
Verified March 2015 by Satoshi Nishizuka, Iwate Medical University.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
Satoshi Nishizuka, Iwate Medical University

Brief Summary:
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.

Condition or disease
Gastric Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

Primary Outcome Measures :
  1. Relapse free survival [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Archived paraffin blocks

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01905969

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Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505
Sponsors and Collaborators
Iwate Medical University
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Responsible Party: Satoshi Nishizuka, Assistant Professor, Iwate Medical University Identifier: NCT01905969    
Other Study ID Numbers: MIAST-NJBMR-12
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Satoshi Nishizuka, Iwate Medical University:
Gastric caner, adjuvant chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases