NCT01916837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

10 months

First QC Date

July 30, 2013

Last Update Submit

August 2, 2013

Conditions

Invasive Breast Cancer

Keywords

Breast cancerFeasibilityGenomic grade index

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The impact of Genomic Grade Index results on adjuvant treatment decision

    12 months

Other Outcomes (1)

  • The success rate of reporting Genomic Grade Index results

    12 months

Study Arms (1)

Single arm

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery.

Other: Sampling of tumor tissueOther: Sampling of tumor tissue after breast cancer surgeryProcedure: Sampling of tumor tissue after breast cancer surgery

Interventions

Sampling of tumor tissueOTHER

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery

Single arm
Sampling of tumor tissue after breast cancer surgeryOTHER

Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 23990869DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

This study includes the collection of fresh-frozen tumor biopsies at the time of breast cancer surgery.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 6, 2013

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

BE(1)