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

NCT ID: NCT01905969

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Biomarker positive

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

No interventions assigned to this group

Biomarker negative

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iwate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Satoshi Nishizuka

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iwate Medical University School of Medicine

Morioka, Iwate, Japan

Site Status

Countries

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Japan

References

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Ishida K, Nishizuka SS, Chiba T, Ikeda M, Kume K, Endo F, Katagiri H, Matsuo T, Noda H, Iwaya T, Yamada N, Fujiwara H, Takahashi M, Itabashi T, Uesugi N, Maesawa C, Tamura G, Sugai T, Otsuka K, Koeda K, Wakabayashi G. Molecular marker identification for relapse prediction in 5-FU-based adjuvant chemotherapy in gastric and colorectal cancers. PLoS One. 2012;7(8):e43236. doi: 10.1371/journal.pone.0043236. Epub 2012 Aug 14.

Reference Type BACKGROUND
PMID: 22905237 (View on PubMed)

Other Identifiers

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MIAST-NJBMR-12

Identifier Type: -

Identifier Source: org_study_id

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