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.
1 other identifier
observational
420
1 country
19
Brief 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+.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedResults Posted
Study results publicly available
October 28, 2016
CompletedOctober 28, 2016
September 1, 2016
2.3 years
March 24, 2016
September 8, 2016
September 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments
Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using the pathologist's choice of IHC and ISH techniques in local laboratories, and using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by local and centralized laboratories. The kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (\<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.
At enrollment
Secondary Outcomes (4)
Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location
At enrollment
Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed
At enrollment
Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages
At enrollment
Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories
At enrollment
Study Arms (1)
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.
Interventions
Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.
Eligibility Criteria
Tumor samples from participants with gastric and gastro-esophageal junction (GEJ) carcinoma.
You may qualify if:
- 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).
You may not qualify if:
- \- Fixatives not allowed: Bouin's solution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Amiens, 80054, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Boulogne-Billancourt, 92104, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Clichy, 92118, France
Unknown Facility
Douai, 59500, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Le Pontet, 84130, France
Unknown Facility
Marseille, 13273, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Montpellier, 34298, France
Unknown Facility
Nantes, 44093, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Rennes, 35000, France
Unknown Facility
Rouen, 76031, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 7, 2016
Study Start
July 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 28, 2016
Results First Posted
October 28, 2016
Record last verified: 2016-09