Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT03485105
Status:
UNKNOWN
Last Update Posted:
2018-04-09
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Prediction of Benefit From Adjuvant Chemotherapy for pT1N1 Gastric Cancer: A Pilot Retrospective Multicenter Cohort Study
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a retrospective study to prove a hypothesis of "adjuvant chemotherapy provides survival benefit for patients of CTX-benefit group in gastric cancer of pT1N1, especially in high-risk group". This study is a pilot study and the result will be used as a reference for the upcoming prospective randomized controlled trial for same issue including estimating sample size. Two high-volume hospitals (Yonsei University Severance Hospital and Samsung Hospital) will participant this pilot study.
FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.
One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.
FFPE sample blocks and clinical information pertaining to the patients who satisfied with selection criteria will be collected from two institutions. The primary end point of this study is disease-free survival (DFS) that is defined as the time from surgery to death or gastric cancer recurrence whichever occurred first; and overall survival (OS) that is defined as time from surgery to death by any causes. Clinical information such as age, sex, histology, Lauren classification, depth of invasion, number of retrieved and metastatic lymph nodes, sizes of tumor, location of tumor, gross type, lympho-vascular invasion, received chemotherapy or not will be centralized.
One or 2 of 3mm core of tumor will be punched from FFPE and it will be delivered through Eppendorf tube to laboratory (Novomics Co. Ltd., Seoul, Korea). RNA will be extracted from the tissue and the pattern of RNA expression will be evaluated and each sample will be categorized into three risk group (high, intermediate, low risk group) and two predictive group (CTX-benefit and no-benefit group) by GMP-grade nProfiler 1TM Stomach Cancer Assay Kit (Novomics Co. Ltd., Seoul, Korea). Both clinical information and classification will be delivered to independent statisticians who are responsible to conduct statistical analyses.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: