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

NCT ID: NCT02852096

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Gastric Cancer HER-2

Keywords

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gastric cancer Her2/neu dual paraffin blocks trastuzumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Dual or Multiple Paraffin Blocks

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

Group Type EXPERIMENTAL

Dual or Multiple Paraffin Blocks

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

One Paraffin Blocks

Intervention Type OTHER

Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks

Interventions

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Dual or Multiple Paraffin Blocks

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

Intervention Type OTHER

One Paraffin Blocks

Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingyong Hou, M.D. & Ph.D.

Role: STUDY_CHAIR

Fudan University

Locations

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180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingyong Hou, M.D. & Ph.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yingyong Hou, M.D.& Ph.D.

Role: primary

References

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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.

Reference Type RESULT
PMID: 20728210 (View on PubMed)

Other Identifiers

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B2015-055R

Identifier Type: -

Identifier Source: org_study_id