Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer

August 2, 2013 updated by: Jules Bordet Institute
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in > 70% of evaluated patients.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study includes patients diagnosed with early-stage invasive breast cancer and operable disease.

Description

Inclusion Criteria:

Histologically confirmed invasive breast cancer meeting the following criteria:

  • T1, T2, or operable T3 disease
  • Zero to three positive lymph nodes and no distant metastases
  • Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance

Exclusion Criteria:

  • No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single arm
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery.
Other: Sampling of tumor tissue
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
Other: Sampling of tumor tissue after breast cancer surgery
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
Procedure: Sampling of tumor tissue after breast cancer surgery
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate in obtaining the Genomic Grade Index in clinical practice
Time Frame: 12 months
To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of Genomic Grade Index results on adjuvant treatment decision
Time Frame: 12 months
The secondary objective was to evaluate the impact of Genomic Grade Index on adjuvant treatment decisions for patients with early breast cancer. This was done by comparing physicians' treatment recommendations before having knowledge of the GGI test results to recommendations with a hypothetical GG-1 and GG-3 result and to the treatment ultimately administered after discussion with the patient.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of reporting Genomic Grade Index results
Time Frame: 12 months
To test the success rate of reporting GGI, a minimum sample size of 137 was calculated to have a power of 90% at a one-sided significance level of 5% using an empirical estimate of variance (null hypothesis H0: p ≤ 0.70 vs. alternative hypothesis HA: p ≥ 0.80).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 2, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1668
  • 2009-015521-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Breast Cancer

Clinical Trials on Sampling of tumor tissue

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe