Trials / Completed
CompletedNCT02731313
Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma
Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 420 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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+.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Trastuzumab | Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2016-04-07
- Last updated
- 2016-10-28
- Results posted
- 2016-10-28
Locations
19 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02731313. Inclusion in this directory is not an endorsement.