Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy
NJBMR
Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 25, 2015
March 1, 2015
1.4 years
July 19, 2013
March 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse free survival
3 years
Study Arms (2)
Biomarker positive
NF-kB(+)/JNK(-) in curatively removed specimens
Biomarker negative
NF-kB(-)/JNK(+) in curatively removed specimens
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- With advanced neoplastic lesions other than gastric cancer.
- Paraffin embedded tissue is not available.
- Unknown S-1 treatment condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iwate Medical University School of Medicine
Morioka, Iwate, 020-8505, Japan
Related Publications (1)
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.
PMID: 22905237BACKGROUND
Biospecimen
Archived paraffin blocks
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 19, 2013
First Posted
July 23, 2013
Study Start
October 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2016
Last Updated
March 25, 2015
Record last verified: 2015-03