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Gastric Cancer, Gastroesophageal Junction CancerNCT02731313

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

An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Trastuzumab
How many people
420 participants
Where
19 sitesFrance
Study dates
Jul 2012to Oct 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Tumor samples from participants with gastric and gastro-esophageal junction (GEJ) carcinoma.

Who may be able to join

  • 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).

Who cannot join

  • Fixatives not allowed: Bouin's solution

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Study site

    Amiens, 80054

  • Study site

    Besançon, 25030

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Brest, 29609

  • Study site

    Clichy, 92118

  • Study site

    Douai, 59500

  • Study site

    La Tronche, 38700

  • Study site

    Le Pontet, 84130

  • Study site

    Marseille, 13273

  • Study site

    Marseille, 13385

  • Study site

    Montpellier, 34295

  • Study site

    Montpellier, 34298

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75571

  • Study site

    Paris, 75679

  • Study site

    Pessac, 33604

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35000

  • Study site

    Rouen, 76031

Other trials in France

About this study

Official title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.

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+.

Being tested
Trastuzumab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabBiological

    Also called Herceptin

    Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.

Study groups in NCT02731313
Study groupRoleWhat they receive
Gastric and Gastro-Esophageal Junction (GEJ) CarcinomaTumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned.
Receives: Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At enrollment

Secondary outcomes (4)

  1. Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location

    Measured: 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

    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.

    Measured: At enrollment

  3. Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages

    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.

    Measured: At enrollment

  4. Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories

    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.

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2016 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02731313
Sponsor's protocol ID
ML27940
Status last verified
Sep 2016
First submitted
24 Mar 2016
Last updated
28 Oct 2016

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by Hoffmann-La Roche at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments (time frame: At enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02731313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.

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