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

Fudan University

Status: Unknown

Conditions: Gastric Cancer; HER-2

Treatments: Other: One Paraffin Blocks; Other: Dual or Multiple Paraffin Blocks

Study type: Interventional

Funder types: Other

Identifiers

NCT02852096

B2015-055R

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

Dual or Multiple Paraffin Blocks

Experimental group

Description:

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

Treatment:

Other: Dual or Multiple Paraffin Blocks

One Paraffin Blocks

Active Comparator group

Description:

Assessing Her2/neu Expression in Gastric Cancer with One Tumor Tissue Paraffin Blocks

Treatment:

Other: One Paraffin Blocks