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Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

Primary Purpose

Gastric Cancer, HER-2

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dual or Multiple Paraffin Blocks
One Paraffin Blocks
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastric cancer, Her2/neu, dual paraffin blocks, trastuzumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment.

Exclusion Criteria:

None.

Sites / Locations

  • 180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual or Multiple Paraffin Blocks

One Paraffin Blocks

Arm Description

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

Outcomes

Primary Outcome Measures

The positive rate of cohort using dual or multiple tumor tissue paraffin blocks

Secondary Outcome Measures

Full Information

First Posted
November 8, 2015
Last Updated
November 9, 2017
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02852096
Brief Title
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
Official Title
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, HER-2
Keywords
gastric cancer, Her2/neu, dual paraffin blocks, trastuzumab

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual or Multiple Paraffin Blocks
Arm Type
Experimental
Arm Description
Assessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks
Arm Title
One Paraffin Blocks
Arm Type
Active Comparator
Arm Description
Assessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks
Intervention Type
Other
Intervention Name(s)
Dual or Multiple Paraffin Blocks
Intervention Description
Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
Intervention Type
Other
Intervention Name(s)
One Paraffin Blocks
Intervention Description
Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks
Primary Outcome Measure Information:
Title
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 to 80; Received curative surgery with primary gastric adenocarcinoma; Did not receive any preoperative treatment. Exclusion Criteria: None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingyong Hou, M.D. & Ph.D.
Email
hou.yingyong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingyong Hou, M.D. & Ph.D.
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingyong Hou, M.D.& Ph.D.
Phone
86-13681972385
Email
hou.yingyong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yingyong Hou, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
20728210
Citation
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. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.
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Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks

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