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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015521-36 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sampling of tumor tissue | Other | Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success rate in obtaining the Genomic Grade Index in clinical practice | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of Genomic Grade Index results on adjuvant treatment decision | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of reporting Genomic Grade Index results | 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 |
Inclusion Criteria:
Histologically confirmed invasive breast cancer meeting the following criteria:
Exclusion Criteria:
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This study includes patients diagnosed with early-stage invasive breast cancer and operable disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23990869 | Derived | Metzger-Filho O, Catteau A, Michiels S, Buyse M, Ignatiadis M, Saini KS, de Azambuja E, Fasolo V, Naji S, Canon JL, Delree P, Coibion M, Cusumano P, Jossa V, Kains JP, Larsimont D, Richard V, Faverly D, Cornez N, Vuylsteke P, Vanderschueren B, Peyro-Saint-Paul H, Piccart M, Sotiriou C. Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer. PLoS One. 2013 Aug 19;8(8):e66848. doi: 10.1371/journal.pone.0066848. eCollection 2013. |
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This study includes the collection of fresh-frozen tumor biopsies at the time of breast cancer surgery.
| Sampling of tumor tissue after breast cancer surgery | Other | Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery |
|
| Sampling of tumor tissue after breast cancer surgery | Procedure | Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery |
|
| 12 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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