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

NCT ID: NCT01916837

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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

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Invasive Breast Cancer

Keywords

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Breast cancer Feasibility Genomic grade index

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm

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

Sampling of tumor tissue

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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Sampling of tumor tissue

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

Intervention Type 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

Intervention Type OTHER

Sampling of tumor tissue after breast cancer surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 23990869 (View on PubMed)

Other Identifiers

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2009-015521-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1668

Identifier Type: -

Identifier Source: org_study_id