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

Not Applicable

• Conditions: Gastric Cancer; HER-2
• Interventions: Other: One Paraffin Blocks; Other: Dual or Multiple Paraffin Blocks

• Registration Number: NCT02852096
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-08
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-13
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One Paraffin Blocks	One Paraffin Blocks	Assessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks
Dual or Multiple Paraffin Blocks	Dual or Multiple Paraffin Blocks	Assessing Her2/neu Expression in Gastric Cancer with Dual or Multiple Tumor Tissue Paraffin Blocks

Primary Outcome Measures

Name	Time	Method
The positive rate of cohort using dual or multiple tumor tissue paraffin blocks	24 months

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China