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

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Roche

Status

Completed

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Treatments

Biological: Trastuzumab

Study type

Observational

Funder types

Industry

Identifiers

NCT02731313
ML27940

Details and patient eligibility

About

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+.

Enrollment

420 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

420 participants in 1 patient group

Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma
Description:
Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned.
Treatment:
Biological: Trastuzumab

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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