Gastric Cancer, Gastroesophageal Junction Cancer Clinical Trial
Official title:
Evaluation of HER-2 Status in Gastric and Gastro-Oesophageal Junction Carcinoma.
The objective of this study is to assess concordance between two different laboratory methods for determination of human epidermal growth factor receptor 2 (HER-2) status in participants with gastric and gastro-esophageal junction carcinomas in routine practice compared to centralized analysis. Immunohistochemistry (IHC) and in situ hybridization (ISH) methods are compared in this study.
| Status | Completed |
| Enrollment | 420 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Kappa Coefficient of Correlation of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments | At enrollment | No | |
| Secondary | Cancer Characteristics: Percentage of Samples with Initial Location of Adenocarcinoma in Stomach versus Esogastric Location | At enrollment | No | |
| Secondary | Cancer Characteristics: Percentage of Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed | At enrollment | No | |
| Secondary | Cancer Characteristics: Percentage of Samples in Each of the Tumor-Node-Metastasis (TNM) Stages | At enrollment | No | |
| Secondary | Weighted Kappa Coefficient for Correlation Between Immunohistochemistry (IHC) 4B5 and Silver in situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories | At enrollment | No |