Clinical trial NCT02731313: Human Epidermal Growth Factor Receptor 2 (HER-2) Status in Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma
Official title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumor samples from participants with gastric and gastro-esophageal junction (GEJ) carcinoma.

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+.


Eligibility criteria: 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

Primary outcomes:
measure: Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments
timeFrame: At enrollment
Secondary outcomes:
measure: Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location
timeFrame: At enrollment
measure: Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed
timeFrame: At enrollment
measure: Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages
timeFrame: At enrollment
measure: Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories
timeFrame: At enrollment
Other outcomes:
Locations:
city: Amiens
country: France
city: Besancon
country: France
city: Boulogne Billancourt
country: France
city: Brest
country: France
city: Clichy
country: France
city: Douai
country: France
city: La Tronche
country: France
city: Le Pontet
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: