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

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ClinicalTrials.gov Identifier: NCT02731313
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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+.

Condition or disease Intervention/treatment
Gastric Cancer, Gastroesophageal Junction Cancer Biological: Trastuzumab

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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.
Study Start Date : July 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Group/Cohort Intervention/treatment
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.
Biological: Trastuzumab
Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.
Other Name: Herceptin




Primary Outcome Measures :
  1. Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments [ Time Frame: At enrollment ]
    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.


Secondary Outcome Measures :
  1. Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location [ Time Frame: At enrollment ]
  2. Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed [ Time Frame: At enrollment ]
    The Lauren classification is based on examination of histologic specimens under the microscope and divides adenocarcinoma of the stomach into 3 types: 1) Diffuse type: tumor cells are poorly differentiated, behave aggressively and tend to scatter throughout the stomach (rather than form glands). This type metastasizes to other parts of the body much quicker than intestinal type tumors, 2) Intestinal type: tumor cells are well differentiated, grow slowly and tend to form glands, 3) Mixed type: this type is made up of both intestinal and diffuse types.

  3. Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages [ Time Frame: At enrollment ]
    The TNM stage system includes information about the size of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N) and whether the cancer has metastasized to other parts of the body (M). In the T classification TX indicates that the main tumor cannot be measured, T1, T2, T3 and T4 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. In the N classification NX indicates that the cancer in nearby lymph nodes cannot be measured, N0 indicates that there is no cancer in nearby lymph nodes, N1, N2 and N3 refer to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. In the M classification MX indicates that the metastasis cannot be measured, M0 indicates that the cancer has not spread to other parts of the body and M1 indicates that the cancer has spread to other parts of the body.

  4. Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories [ Time Frame: At enrollment ]
    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 IHC 4B5 and silver ISH (SISH) in centralized laboratories. The weighted kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by IHC 4B5 and SISH. The weighted 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tumor samples from participants with gastric and gastro-esophageal junction (GEJ) carcinoma.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731313


Locations
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France
Amiens, France, 80054
Besancon, France, 25030
Boulogne Billancourt, France, 92104
Brest, France, 29609
Clichy, France, 92118
Douai, France, 59500
La Tronche, France, 38700
Le Pontet, France, 84130
Marseille, France, 13273
Marseille, France, 13385
Montpellier, France, 34295
Montpellier, France, 34298
Nantes, France, 44093
Paris, France, 75571
Paris, France, 75679
Pessac, France, 33604
Reims, France, 51092
Rennes, France, 35000
Rouen, France, 76031
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02731313     History of Changes
Other Study ID Numbers: ML27940
First Posted: April 7, 2016    Key Record Dates
Results First Posted: October 28, 2016
Last Update Posted: October 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents