NCT01916837

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2013-08-06
• Last updated: 2013-08-06

Locations

1 site across 1 country: Belgium