Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
1 other identifier
interventional
600
1 country
1
Brief Summary
One paraffin block is routinely used for Human Epidermal Growth Factor Receptor 2 (Her2/neu) immunohistochemistry (IHC) assessment. Here, investigators investigated if picking two or multiple paraffin blocks for Her2/neu evaluation is an economical, efficient and practical method, which may reduce false-negativity of Her2/neu IHC assessment due to intratumoral heterogeneity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Nov 2015
Typical duration for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 8, 2015
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 13, 2017
November 1, 2017
4.1 years
November 8, 2015
November 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks
24 months
Study Arms (2)
Dual or Multiple Paraffin Blocks
EXPERIMENTALAssessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks
One Paraffin Blocks
ACTIVE COMPARATORAssessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks
Interventions
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks
Eligibility Criteria
You may qualify if:
- Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PMID: 20728210RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yingyong Hou, M.D. & Ph.D.
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2015
First Posted
August 2, 2016
Study Start
November 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 13, 2017
Record last verified: 2017-11