Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

NCT ID: NCT02731313

Last Updated: 2016-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

Brief Summary

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The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry \[IHC\] and in situ hybridization \[ISH\] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.

Detailed Description

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Conditions

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Gastric Cancer, Gastroesophageal Junction Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma

Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned.

Trastuzumab

Intervention Type BIOLOGICAL

Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.

Interventions

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Trastuzumab

Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.

Intervention Type BIOLOGICAL

Other Intervention Names

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Herceptin

Eligibility Criteria

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Inclusion Criteria

* Tumor samples with histologically confirmed gastric or gastro-esophageal junction (GEJ) adenocarcinoma, any stage
* Samples with sufficient tumor material for centralized analysis
* Samples fixed and embedded in paraffin (formalin-fixed paraffin-embedded tissue \[FFPET\] samples).

Exclusion Criteria

\- Fixatives not allowed: Bouin's solution
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Amiens, , France

Site Status

Besançon, , France

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Boulogne-Billancourt, , France

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Brest, , France

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Clichy, , France

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Douai, , France

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La Tronche, , France

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Le Pontet, , France

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Marseille, , France

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Marseille, , France

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Montpellier, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Reims, , France

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Rennes, , France

Site Status

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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ML27940

Identifier Type: -

Identifier Source: org_study_id