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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02852096
• Other study ID #: B2015-055R
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2015
• Last updated: November 9, 2017
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Shanghai Zhongshan Hospital
• Contact: Yingyong Hou, M.D. & Ph.D.
• Email: hou.yingyong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Gastric Cancer
• HER-2
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & 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, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The positive rate of cohort using dual or multiple tumor tissue paraffin blocks		24 months